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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73734

91 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 31, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
American Surgical Company

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

91 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 91

American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1721-2016
Recall number
Z-1721-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
351 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot Number:/ 2015/08 BH 2015/09 BP 2015/10 BM 2015/11 BL 2015/12 AX 2015/12 CR 2016/01 AN

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 2 of 91

American Surgical Delicot 30mm x 70mm Ref: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1722-2016
Recall number
Z-1722-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
689 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot number: 2015/08 BH 2015/09 BP 2015/10 BM 2015/11 BL 2015/12 AX 2015/12 CR 2016/01 AN 2015/08 BZ 2015/10 AG 2015/09 AW 2015/10 CD 2015/11 AZ 2015/11 BT 2015/12 AY 2015/11 BH 2015/12 CO 2015/12 DD

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 3 of 91

American Surgical Americot Blue 1/4" x 1/4" Ref Number: 20-01S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1723-2016
Recall number
Z-1723-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
54 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot number: 2015/09 AB 2015/12 BS 2015/12 BN 2016/01 AC

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 4 of 91

American Surgical Americot Blue 1/2" x 1/2" Ref Number: 20-04S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1724-2016
Recall number
Z-1724-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
262 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/08 CM 2015/09 AJ 2015/10 BI 2015/11 AY 2015/12 CJ

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 5 of 91

American Surgical Americot Blue 1/2" x 1" Ref Number: 20-05S Product Usage: Neurosurgical and Nonneurosurgical Sponges Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1725-2016
Recall number
Z-1725-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
35 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 AB

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 6 of 91

American Surgical Americot Blue 1/2" x 1.5" Ref Number: 20-06S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1726-2016
Recall number
Z-1726-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
78 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 BR 2015/12 BO 2015/12 BU

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 7 of 91

American Surgical Americot Blue 1/2" x 3" Ref Number: 20-07S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1727-2016
Recall number
Z-1727-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
33 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/12 CG

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 8 of 91

American Surgical Americot Blue 1" x 3" Ref Number: 20-10S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1728-2016
Recall number
Z-1728-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
103 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 AL 2015/11 BZ 2015/12 CC 2016/01 AB

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 9 of 91

American Surgical Americot Blue 3/8" x 3/4" Ref Number: 20-14S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1729-2016
Recall number
Z-1729-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
37 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 CU 2015/11 BK 2015/12 DB

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 10 of 91

American Surgical Americot Blue 1/8" x 1/8" Ref Number: 20-19S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1730-2016
Recall number
Z-1730-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
4 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2016/01 AD

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 11 of 91

American Surgical Americot Blue 3/8" x 3/8" Ref Number: 20-22S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1731-2016
Recall number
Z-1731-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
24 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 AR 2015/11 BX

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 12 of 91

American Surgical Americot Blue 3/8" x 2" Ref Number: 20-26S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1732-2016
Recall number
Z-1732-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
15 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 BJ

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 13 of 91

American Surgical Americot Blue 1/4" x 1.5" Ref Number: 20-30S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1733-2016
Recall number
Z-1733-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
22 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/08 BL

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 14 of 91

American Surgical Americot White 1.5 cm x 5.5 cm Ref Number: 20-31SW Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1734-2016
Recall number
Z-1734-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
35 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/11 AV 2015/12 BC

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 15 of 91

American Surgical Americot Blue 1/2" x 2" Ref Number: 20-32S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1735-2016
Recall number
Z-1735-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
37 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 CO 2016/01 AH 2016/01 AE

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 16 of 91

American Surgical Ultracot 5 mm x 8 mm Ref Number: 23-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1736-2016
Recall number
Z-1736-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
114 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/08 CG 2015/09 CA

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 17 of 91

American Surgical Ultracot 5 mm x 8 mm (Glassine) Ref Number: 23-01G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1737-2016
Recall number
Z-1737-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
11 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 AJ 2015/10 CP 2015/11 BM

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 18 of 91

American Surgical Ultracot 5 mm x 13 mm (Glassine) Ref Number: 23-02G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1738-2016
Recall number
Z-1738-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
15 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 AY 2015/11 AA 2015/12 BB

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 19 of 91

American Surgical Ultracot 10 mm x 13 mm (Glassine) Ref Number: 23-03G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1739-2016
Recall number
Z-1739-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
41 Boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 AH 2015/10 CE 2015/11 AB

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 20 of 91

American Surgical Ultracot 15 mm x 20 mm Ref Number: 23-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1740-2016
Recall number
Z-1740-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
22 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/12 BP

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 21 of 91

American Surgical Ultracot 15 mm x 20 mm (Glassine) Ref Number: 23-04G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1741-2016
Recall number
Z-1741-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
39 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 CJ 2015/11 AC 2015/12 BQ

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 22 of 91

American Surgical Ultracot 6 mm x 50 mm Ref Number: 23-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1742-2016
Recall number
Z-1742-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
1 box

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 CT

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 23 of 91

American Surgical Ultracot 9 mm x 50 mm (Glassine) Ref Number: 23-07G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1743-2016
Recall number
Z-1743-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
32 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 CF 2015/12 AO

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 24 of 91

American Surgical Ultracot 13 mm x 60 mm Ref Number: 23-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1744-2016
Recall number
Z-1744-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
23 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 AP

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 25 of 91

American Surgical Ultracot 13 mm x 60 mm (Glassine) Ref Number: 23-08G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1745-2016
Recall number
Z-1745-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
45 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 AI 2015/11 AD 2015/11 BU

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 26 of 91

American Surgical Ultracot 20 mm x 60 mm Ref Number: 23-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1746-2016
Recall number
Z-1746-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
33 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/08 CJ

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 27 of 91

American Surgical Ultracot 20 mm x 60 mm (Glassine) Ref Number: 23-09G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1747-2016
Recall number
Z-1747-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
155 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 AZ 2015/10 AD 2015/10 BQ 2015/10 CQ 2015/11 AE

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 28 of 91

American Surgical Ultracot 30 mm x 70 mm Ref Number: 23-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1748-2016
Recall number
Z-1748-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
2 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/11 CG

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 29 of 91

American Surgical Ultracot 30 mm x 70 mm (Glassine) Ref Number: 23-10G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1749-2016
Recall number
Z-1749-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
23 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 AE 2015/10 BP

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 30 of 91

American Surgical Ultracot 15 mm x 15 mm (Glassine) Ref Number: 23-12G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1750-2016
Recall number
Z-1750-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
6 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 AF

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 31 of 91

American Surgical Ultracot 30 mm x 90 mm (Glassine) Ref Number: 23-15G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1751-2016
Recall number
Z-1751-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
33 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 BK

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 32 of 91

American Surgical Ultracot 70 mm x 10090 mm Ref Number: 23-24 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1752-2016
Recall number
Z-1752-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
27 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 BZ 2015/11 BA

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 33 of 91

American Surgical Cotton Balls-Strung 1/4" Ref Number: 30-00 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1753-2016
Recall number
Z-1753-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
87 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 CM 2015/11 AO 2015/12 BR

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 34 of 91

American Surgical Cotton Balls-Strung 3/8" Ref Number: 30-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1754-2016
Recall number
Z-1754-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
13 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 BN

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 35 of 91

American Surgical Cotton Balls-Strung 1/2" Ref Number: 30-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1755-2016
Recall number
Z-1755-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
182 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 BN

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 36 of 91

American Surgical Cotton Balls-Strung 3/4" Ref Number: 30-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1756-2016
Recall number
Z-1756-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
70 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 AD 2015/11 AP 2015/12 CE 2015/12 DA

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 37 of 91

American Surgical Cotton Balls-Strung 1" Ref Number: 30-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1757-2016
Recall number
Z-1757-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
237 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/08 AI 2015/09 AA 2015/09 CL 2015/10 AT 2015/11 CH 2015/12 CB 2015/12 AJ

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 38 of 91

American Surgical Cotton Balls-Strung 1.25" Ref Number: 30-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1758-2016
Recall number
Z-1758-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
25 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 CK 2015/10 BF

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 39 of 91

American Surgical Cotton Balls-Strung 1/8" Ref Number: 30-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1759-2016
Recall number
Z-1759-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
34 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: Lot Number 2015/11 AL 2015/12 AS 2015/12 BD 2015/12 DJ

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 40 of 91

American Surgical Cotton Balls-Non-Strung 3/4" Ref Number: 31-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1760-2016
Recall number
Z-1760-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
10 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 AO

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 41 of 91

American Surgical Cotton Balls-Non-Strung 1" Ref Number: 31-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1761-2016
Recall number
Z-1761-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
3 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 BR

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 42 of 91

American Surgical Cotton Balls-Non-Strung 1/8" Ref Number: 31-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1762-2016
Recall number
Z-1762-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
7 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/12 AW

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 43 of 91

American Surgical Tonsil Sponges 1" Large Ref Number: 50-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1763-2016
Recall number
Z-1763-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
4 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/12 BE

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 44 of 91

American Surgical Ray-Cot 1/4" x 1/4" Ref Number: 60-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1764-2016
Recall number
Z-1764-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
165 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 AX 2015/10 BU 2015/10 BZ 2015/11 BN 2015/12 BK 2015/12 AF 2015/12 CL

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 45 of 91

American Surgical Ray-Cot 1/4" x 3" Ref Number: 60-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1765-2016
Recall number
Z-1765-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
3 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/12 AA

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 46 of 91

American Surgical Ray-Cot 1/2" x 1/2" Ref Number: 60-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1766-2016
Recall number
Z-1766-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
266 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/08 AO 2015/09 BU 2015/11 BW 2015/12 BX 2015/12 DN

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 47 of 91

American Surgical Ray-Cot 1/2" x 1" Ref Number: 60-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1767-2016
Recall number
Z-1767-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
165 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: Lot Number 2015/09 BV 2015/11 BE 2015/12 AG 2015/12 AV 2015/12 AB

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 48 of 91

American Surgical Ray-Cot 1/2" x 1.5" Ref Number: 60-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1768-2016
Recall number
Z-1768-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
28 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/11 AJ

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 49 of 91

American Surgical Ray-Cot 1/2" x 3" Ref Number: 60-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1769-2016
Recall number
Z-1769-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
449 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 AC 2015/09 BH 2015/10 AA 2015/10 BJ 2015/11 BC 2015/12 AU 2015/12 AK 2015/12 CK

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 50 of 91

American Surgical Ray-Cot 1" x 1" Ref Number: 60-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1770-2016
Recall number
Z-1770-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
102 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 BB 2015/12 BM

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 51 of 91

American Surgical Ray-Cot 1" x 3" Ref Number: 60-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1771-2016
Recall number
Z-1771-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
209 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/08 CD 2015/09 CB 2015/10 AV 2015/12 BL

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 52 of 91

American Surgical Ray-Cot 3" x 3" Ref Number: 60-15 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1772-2016
Recall number
Z-1772-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
16 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/11 AT

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 53 of 91

American Surgical Ray-Cot 1.5" x 3" Ref Number: 60-22 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1773-2016
Recall number
Z-1773-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
27 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 BV 2015/10 CC 2015/12 CM

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 54 of 91

American Surgical Ray-Cot 1/2" x 2" Ref Number: 60-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1774-2016
Recall number
Z-1774-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
38 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 CS 2015/11 CD 2015/12 BJ

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 55 of 91

American Surgical Delicot 5 mm x 8 mm Ref Number: 63-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1775-2016
Recall number
Z-1775-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
287 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/08 CF 2015/09 CI 2015/10 CM 2015/11 AH 2015/10 CA 2015/11 AM 2015/11 BO 2015/12 AL 2015/11 BS 2015/11 BV 2015/11 BY 2015/12 AT 2015/12 BF 2015/12 CA

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 56 of 91

American Surgical Delicot non-xray 5 mm x 8 mm Ref Number: 63-01 Non X-Ray Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1776-2016
Recall number
Z-1776-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
24 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 BY 2015/10 CV

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 57 of 91

American Surgical Delicot-J 5 mm x 8 mm Ref Number: 63-01J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1777-2016
Recall number
Z-1777-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
27 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 BS

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 58 of 91

American Surgical Delicot 5 mm x 13 mm Ref Number: 63-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1778-2016
Recall number
Z-1778-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
97 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/08 CK 2015/10 BE 2015/10 CN 2015/11 AI 2015/12 AQ

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 59 of 91

American Surgical Delicot non-xray 5 mm x 13 mm Ref Number: 63-02 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1779-2016
Recall number
Z-1779-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
21 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10R CL

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 60 of 91

American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1780-2016
Recall number
Z-1780-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
442 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/08 CL 2015/09 BT 2015/10 BT 2015/11 BG 2015/12 AI 2015/12 CF 2015/12 CQ 2016/01 AK 2016/01 AA

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 61 of 91

American Surgical Delicot non-xray 10 mm x 13 mm Ref Number: 63-03 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1781-2016
Recall number
Z-1781-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
4 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 CB

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 62 of 91

American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1782-2016
Recall number
Z-1782-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
99 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 AQ 2015/10 BC 2015/10 BW 2015/11 AK 2015/11 CJ 2015/12 AH 2015/12 CH

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 63 of 91

American Surgical Delicot-J 15 mm x 20 mm Ref Number: 63-04J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1783-2016
Recall number
Z-1783-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
68 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2016/01 AQ

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 64 of 91

American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1784-2016
Recall number
Z-1784-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
99 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 AQ 2015/10 BC 2015/10 BW 2015/11 AK 2015/11 CJ 2015/12 AH 2015/12 CH

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 65 of 91

American Surgical Delicot 6 mm x 50 mm Ref Number: 63-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1785-2016
Recall number
Z-1785-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
113 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 BC 2015/11 BB

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 66 of 91

American Surgical Delicot 9 mm x 50 mm Ref Number: 63-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1786-2016
Recall number
Z-1786-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
315 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: Lot Number 2015/08 CE 2015/10 AS 2015/11 BD 2015/10 BX 2015/12 BH 2015/12 BW 2015/12 CP 2015/12 DC

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 67 of 91

American Surgical Delicot 13 mm x 60 mm Ref Number: 63-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1787-2016
Recall number
Z-1787-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
409 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 AK 2015/09 BS 2015/10 AY 2015/10 BO 2015/11 BF 2015/12 AC 2015/12 CI 2015/12 CS 2015/12 CX

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 68 of 91

American Surgical Delicot-J 13 mm x 60 mm Ref Number: 63-08J (Japan only) Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1788-2016
Recall number
Z-1788-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
33 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 BN

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 69 of 91

American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1789-2016
Recall number
Z-1789-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
343 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 BK 2015/10 AZ 2015/10 CK 2015/10 CO 2015/10 CW 2015/11 BJ 2015/11 BR

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 70 of 91

American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1790-2016
Recall number
Z-1790-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
338 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/08 BZ 2015/10 AG 2015/09 AW 2015/10 CD 2015/11 AZ 2015/11 BT 2015/12 AY 2015/11 BH 2015/12 CO 2015/12 DD

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 71 of 91

American Surgical Delicot-J 30 mm x 70 mm Ref Number: 63-10J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1791-2016
Recall number
Z-1791-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
37 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 BH 2015/11 CC

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 72 of 91

American Surgical Delicot X 6 mm x 50 mm Ref Number: 63x06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1792-2016
Recall number
Z-1792-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
3 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 CG

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 73 of 91

American Surgical Delicot X 9 mm x 50 mm Ref Number: 63x07 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1793-2016
Recall number
Z-1793-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
1 box

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 CH

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 74 of 91

American Surgical Uniqcot 1/4" x 1/4" Ref Number: 67-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1794-2016
Recall number
Z-1794-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
39 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 CN 2015/10 AU

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 75 of 91

American Surgical Uniqcot 1/2" x 1/2" Ref Number: 67-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1795-2016
Recall number
Z-1795-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
7 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2016/01 AG

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 76 of 91

American Surgical Uniqcot 1/2" x 1.5" Ref Number: 67-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1796-2016
Recall number
Z-1796-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
4 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/12 CD

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 77 of 91

American Surgical Uniqcot 1/2" x 3" Ref Number: 67-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1797-2016
Recall number
Z-1797-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
15 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/10 AN

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 78 of 91

American Surgical Uniqcot 1/2" x 2" Ref Number: 67-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1798-2016
Recall number
Z-1798-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
3 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 BG

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 79 of 91

American Surgical Cylindrical Sponges-Strung 1/2" x 1.5" Ref Number: 70-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1799-2016
Recall number
Z-1799-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
11 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/11 AN

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 80 of 91

American Surgical Telfa 3/8" x 3" Ref Number: 80-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1800-2016
Recall number
Z-1800-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
11 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/12 AD

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 81 of 91

American Surgical Telfa 1/2" x 1/2" Ref Number: 80-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1801-2016
Recall number
Z-1801-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
24 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/08 BK

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 82 of 91

American Surgical Telfa 1/2" x 1.5" Ref Number: 80-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1802-2016
Recall number
Z-1802-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
4 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot number:2015/11 BP

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 83 of 91

American Surgical Telfa 1/2" x 3" Ref Number: 80-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1803-2016
Recall number
Z-1803-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
178 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 CC 2015/10 BL 2015/12 BI 2016/01 AP 2015/12 CZ

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 84 of 91

American Surgical Telfa 3/4" x 3" Ref Number: 80-11 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1804-2016
Recall number
Z-1804-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
7 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/12 AP

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 85 of 91

American Surgical Telfa 1" x 1" Ref Number: 80-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1805-2016
Recall number
Z-1805-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
10 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/08 CI 2015/12 CU

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 86 of 91

American Surgical Telfa 1" x 3" Ref Number: 80-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1806-2016
Recall number
Z-1806-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
57 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/08 BS 2015/12 AR

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 87 of 91

American Surgical Policot 1/4" x 1/4" Ref Number: 90-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1807-2016
Recall number
Z-1807-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
3 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 BE

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 88 of 91

American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1808-2016
Recall number
Z-1808-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
5 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 BI

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 89 of 91

American Surgical Policot 1/2" x 1.5" Ref Number: 90-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1809-2016
Recall number
Z-1809-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
4 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2015/09 BA

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 90 of 91

American Surgical Policot 1/2" x 2" Ref Number: 90-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1810-2016
Recall number
Z-1810-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
2 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: 2016/01 AF

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

device · product 91 of 91

Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1811-2016
Recall number
Z-1811-2016
Initiated
March 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
American Surgical Company
Quantity
16 BOXES

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product packaging defective compromising sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging defective compromising sterility

Code information

Lot numbers: Lot Number 2015/09 AI 2015/10 CR 2015/12 BV 2015/12 CV

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.