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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71911

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

Open FDA event record

Event summary

Timeline bucket
August 07, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
International Biophysics Corp.

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

3 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 3

IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.

Z-2422-2015
Recall number
Z-2422-2015
Initiated
August 07, 2015
Classification
Class II
Status
Terminated
Quantity
100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.

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

It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.

Code information

033115-3445

Distribution pattern

Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa

device · product 2 of 3

IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40 Product Usage: The IBC Aortic Punch is a single-use, disposable surgical punch used to create an opening in the wall of the aorta to prepare a site for anastomosis.

Z-2423-2015
Recall number
Z-2423-2015
Initiated
August 07, 2015
Classification
Class II
Status
Terminated
Quantity
10,330 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.

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

It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.

Code information

042415-3488, 022515-3372, 02215-3374, 022515-3372, 022515-3371, 022515-3373, 022515-3382, 022515-3383, 022515-3384, 022515-3385, 022515-3386, 040615-3452, 040615-3453, 040615-3449, 040615-3450, 040615-3451, 040615-3448, 040615-3447, 050815-3510, 050815-3509, 050815-3511, 050815-3512, 052715-3602, 060315-3603, 031215-3412, 022515-3387, 022515-3388, 033015-3442, 042415-3488

Distribution pattern

Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa

device · product 3 of 3

IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.

Z-2424-2015
Recall number
Z-2424-2015
Initiated
August 07, 2015
Classification
Class II
Status
Terminated
Quantity
771 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.

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

It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.

Code information

031715-3418, 050815-3513, 052115-3540, 033015-3435, 052115-3542, 031615-3417, 050815-3514, 052115-3543, 033015-3436, 050815-3515, 060915-3578, 041715-3478, 033015-3437, 050815-3516, 052215-3545, 042015-3482, 052115-3541

Distribution pattern

Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa