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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90072

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

Open FDA event record

Event summary

Timeline bucket
February 22, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Busse Hospital Disposables, Inc.

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

58 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 58

I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822

Z-1147-2022
Recall number
Z-1147-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
2475

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2020514 2020525 2020734 2120255 2120304 2120325 2120439 UDI: 00849233010017

Distribution pattern

Nationwide

device · product 2 of 58

Procedure Tray Catalog 1065

Z-1148-2022
Recall number
Z-1148-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
46 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2030699 2130342 UDI: 00849233003354

Distribution pattern

Nationwide

device · product 3 of 58

Cervical Tray Catalog 1089

Z-1149-2022
Recall number
Z-1149-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
80

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2030899 2130011 2130214 2130789 2130798 2130898 2131135 UDI: 00849233000414

Distribution pattern

Nationwide

device · product 4 of 58

Lumbar Tray Catalog 1091

Z-1150-2022
Recall number
Z-1150-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
330 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2030899 2130011 2130214 2130789 2130798 2130898 2131135 UDI: 00849233000247

Distribution pattern

Nationwide

device · product 5 of 58

Single Shot Epidural Tray Catalog 1165

Z-1151-2022
Recall number
Z-1151-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
20 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2130290 2131184 UDI: 00849233006485

Distribution pattern

Nationwide

device · product 6 of 58

Single Shot Epidural Tray Catalog 1292

Z-1152-2022
Recall number
Z-1152-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
60 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2130282 2130576 2131060 UDI: 00849233003644

Distribution pattern

Nationwide

device · product 7 of 58

Epidural Tray Catalog 1307

Z-1153-2022
Recall number
Z-1153-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
64 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2131254 UDI: 00849233003668

Distribution pattern

Nationwide

device · product 8 of 58

Universal Tray Catalog 1567

Z-1154-2022
Recall number
Z-1154-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
96 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2130419 2130880 2131187 UDI: 00849233005655

Distribution pattern

Nationwide

device · product 9 of 58

Epidural Tray Catalog 1577

Z-1155-2022
Recall number
Z-1155-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
80 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2130426 2130801 2131032 2131138 2131290 UDI: 00849233006546

Distribution pattern

Nationwide

device · product 10 of 58

Port Tray Catalog 7607

Z-1156-2022
Recall number
Z-1156-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
576 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2010357 2110129 2110181 2110225 2110252 UDI: 00849233014176

Distribution pattern

Nationwide

device · product 11 of 58

I.V. Start Kit Catalog 8172

Z-1157-2022
Recall number
Z-1157-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
4218 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2020561 2020560 2020650 2120089 2120018 2120344 2120442 2120645 2120768 2120911 UDI: 00849233015883

Distribution pattern

Nationwide

device · product 12 of 58

Nerve Block Tray Catalog Number: 8415

Z-1158-2022
Recall number
Z-1158-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
420 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2030832 2031190 2130252 2130629 2130742 2131125 2131223 UDI: 00849233016811

Distribution pattern

Nationwide

device · product 13 of 58

Single Shot Epidural Tray Catalog Number: 8417

Z-1159-2022
Recall number
Z-1159-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
400 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2130077 2130313 2130630 2130945 2131091 UDI: 00849233016804

Distribution pattern

Nationwide

device · product 14 of 58

Nerve Block Tray Catalog Number: 9342

Z-1160-2022
Recall number
Z-1160-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
64 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2031019S 2130222S UDI: 00849233009073

Distribution pattern

Nationwide

device · product 15 of 58

Universal Nerve Block Tray Catalog Number: 9779

Z-1161-2022
Recall number
Z-1161-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
400 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2031030 2130009 2130328 2130645 UDI: 00849233012134

Distribution pattern

Nationwide

device · product 16 of 58

Universal Nerve Block Tray Catalog Number: 9818

Z-1162-2022
Recall number
Z-1162-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
60 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2030783 2031093 2130287 2130412 2130681 2131043 UDI:00849233012042

Distribution pattern

Nationwide

device · product 17 of 58

MBB Tray Catalog Number: 9882

Z-1163-2022
Recall number
Z-1163-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
60 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: Lot 2130220 2130445 2131063 UDI: 00849233000179

Distribution pattern

Nationwide

device · product 18 of 58

Pain Tray Catalog Number: 9883

Z-1164-2022
Recall number
Z-1164-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
421 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2031092 2130020 2130288 2130670 2130020 2130905 2131181 2131317 UDI: 00849233012158

Distribution pattern

Nationwide

device · product 19 of 58

Stereo Breast Biopsy Tray Catalog Number: 2383R1

Z-1165-2022
Recall number
Z-1165-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
23 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2130565 UDI: 00849233004344

Distribution pattern

Nationwide

device · product 20 of 58

CVC Dressing Change Kit Catalog Number: 2491R1

Z-1166-2022
Recall number
Z-1166-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2020472 2020519 2020651 2020759 UDI: 00849233004481

Distribution pattern

Nationwide

device · product 21 of 58

Nerve Block Tray Catalog Number: 3764R2

Z-1167-2022
Recall number
Z-1167-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
250 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2030839 2030974 2130490 2130900 2131293 UDI: 00849233015197

Distribution pattern

Nationwide

device · product 22 of 58

Cervical Tray Catalog Number: 3765R2

Z-1168-2022
Recall number
Z-1168-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2031213S 2130221S UDI: 00849233015203

Distribution pattern

Nationwide

device · product 23 of 58

Single Shot Epidural Tray Catalog Number: 6183R1

Z-1169-2022
Recall number
Z-1169-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
425 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2030967 2031172 2031272 2130029 2130151 2130298 2130357 2130459 2130527 2130593 2130716 2130863 2130975 2131088 2131120 2131224 2131248 UDI: 00849233007857

Distribution pattern

Nationwide

device · product 24 of 58

Sterile Epidural Tray Catalog Number: 6259R2

Z-1170-2022
Recall number
Z-1170-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2130839 2131167 2131230 2131210 UDI: 00849233000278

Distribution pattern

Nationwide

device · product 25 of 58

Nerve Block Tray Catalog Number: 6796R3

Z-1171-2022
Recall number
Z-1171-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2031026 2031218 2130212 2130896 UDI: 00849233015944

Distribution pattern

Nationwide

device · product 26 of 58

Single Shot Epidural Tray Catalog Number: 6797R2

Z-1172-2022
Recall number
Z-1172-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2030835 2031025 2031217 2130006 UDI: 00849233014657

Distribution pattern

Nationwide

device · product 27 of 58

Pump Refill Kit Catalog Number: 7347R1

Z-1173-2022
Recall number
Z-1173-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2030921 2130507 UDI: 00849233009363

Distribution pattern

Nationwide

device · product 28 of 58

Single Shot Epidural Tray - 18G Catalog Number: 8139R2

Z-1174-2022
Recall number
Z-1174-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
20 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2031049 2131128 UDI: 00849233015890

Distribution pattern

Nationwide

device · product 29 of 58

Joint Injection Tray Catalog Number: 8561R1

Z-1175-2022
Recall number
Z-1175-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
480 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: Lot 2031105 2130068 2130167 2130508 2130862 2131115 UDI: 00849233016712

Distribution pattern

Nationwide

device · product 30 of 58

Core Biopsy Tray Catalog Number: 8673R4

Z-1176-2022
Recall number
Z-1176-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
285 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2031043 2130119 2130382 2130830 2130997 UDI: 00849233017092

Distribution pattern

Nationwide

device · product 31 of 58

Bone Marrow Biopsy Tray Catalog Number: 8917R1

Z-1177-2022
Recall number
Z-1177-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
80 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2020741 2120119 2120119 2120342 2120630 UDI: 00849233002012

Distribution pattern

Nationwide

device · product 32 of 58

Procedural Accessory Kit Catalog Number: 9665R2

Z-1178-2022
Recall number
Z-1178-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
250 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2031038 UDI: 00860000210461

Distribution pattern

Nationwide

device · product 33 of 58

3.2MM Pellet Insertion Tray Catalog Number: B1144

Z-1179-2022
Recall number
Z-1179-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
120 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2010270 2110081 2110173 2110220 UDI: 00849233003835

Distribution pattern

Nationwide

device · product 34 of 58

"3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351

Z-1180-2022
Recall number
Z-1180-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
120 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2110082 2110174 2110254 2110221 UDI: 00849233004733

Distribution pattern

Nationwide

device · product 35 of 58

SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352

Z-1181-2022
Recall number
Z-1181-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2010298 UDI: 00849233004719

Distribution pattern

Nationwide

device · product 36 of 58

SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352R1

Z-1182-2022
Recall number
Z-1182-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
120 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2110100 2110083 2110226 2110262 UDI: 00849233004719

Distribution pattern

Nationwide

device · product 37 of 58

SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354

Z-1183-2022
Recall number
Z-1183-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2010304 UDI: 00849233004641

Distribution pattern

Nationwide

device · product 38 of 58

SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1

Z-1184-2022
Recall number
Z-1184-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
90 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2110102 2110090 2110268 UDI: 00849233004641

Distribution pattern

Nationwide

device · product 39 of 58

4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1360

Z-1185-2022
Recall number
Z-1185-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2010336 UDI: 00849233004627

Distribution pattern

Nationwide

device · product 40 of 58

4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1362

Z-1186-2022
Recall number
Z-1186-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2110098 UDI: 00849233004610

Distribution pattern

Nationwide

device · product 41 of 58

SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363

Z-1187-2022
Recall number
Z-1187-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2010337 UDI:00849233006515

Distribution pattern

Nationwide

device · product 42 of 58

SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363R1

Z-1188-2022
Recall number
Z-1188-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
60 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2110127 2110269 UDI: 00849233006515

Distribution pattern

Nationwide

device · product 43 of 58

SS 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1365R1

Z-1189-2022
Recall number
Z-1189-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
60 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2110128 2110279 UDI: 00849233004412

Distribution pattern

Nationwide

device · product 44 of 58

SS 3.5MM Diamond Tip Trocar - Large Gloves Catalog Number: B1547

Z-1190-2022
Recall number
Z-1190-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
60 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2110054 2110116 UDI: 00849233005365

Distribution pattern

Nationwide

device · product 45 of 58

SS 3.5MM Diamond Tip Trocar - Medium Gloves Catalog Number: B1555

Z-1191-2022
Recall number
Z-1191-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
60 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: Lot 2110053 2110115 UDI: 00849233005402

Distribution pattern

Nationwide

device · product 46 of 58

SS 4.5MM DIAMOND TIP TROCAR WITH LARGE GLOVES Catalog Number:B1559

Z-1192-2022
Recall number
Z-1192-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2110052 UDI: 00849233005419

Distribution pattern

Nationwide

device · product 47 of 58

SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560

Z-1193-2022
Recall number
Z-1193-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2110059 UDI: 00849233005426

Distribution pattern

Nationwide

device · product 48 of 58

Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568

Z-1194-2022
Recall number
Z-1194-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2130338 2130562 UDI: 00849233005525

Distribution pattern

Nationwide

device · product 49 of 58

Male SS 4.5MM Pellet Insertion Tray Catalog Number: B1570

Z-1195-2022
Recall number
Z-1195-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
48 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2130324 UDI: 00849233005556

Distribution pattern

Nationwide

device · product 50 of 58

Pellet Insertion Tray Catalog Number: B1654

Z-1196-2022
Recall number
Z-1196-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2130616 UDI: 00849233006027

Distribution pattern

Nationwide

device · product 51 of 58

3.2MM Pellet Insertion Tray Catalog Number: B7345R1

Z-1197-2022
Recall number
Z-1197-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
250 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2031074 2031227 2130194 2130535 2130783 UDI: 00849233016996

Distribution pattern

Nationwide

device · product 52 of 58

SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1

Z-1198-2022
Recall number
Z-1198-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
300 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2030982 2031072 2130198 2130352 2130706 2130876 UDI: 00849233002227

Distribution pattern

Nationwide

device · product 53 of 58

4.5 MM Pellet Insertion Tray Catalog Number: B8121R1

Z-1199-2022
Recall number
Z-1199-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
99 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2031076 2130823 UDI:00849233017306

Distribution pattern

Nationwide

device · product 54 of 58

SS 4.5MM Pellet Insertion Tray Catalog Number:B8128R1

Z-1200-2022
Recall number
Z-1200-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2130197 UDI: 00849233001855

Distribution pattern

Nationwide

device · product 55 of 58

Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1

Z-1201-2022
Recall number
Z-1201-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
1040 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: Lot 2030875 2030980 2031048 2031048 2031096 2031048 2031096 2130563 2130722 UDI: 00849233011182

Distribution pattern

Nationwide

device · product 56 of 58

Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1

Z-1202-2022
Recall number
Z-1202-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
360 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2031047 2031162 2130578 2130723 UDI: 00849233011151

Distribution pattern

Nationwide

device · product 57 of 58

3.2MM Pellet Insertion Tray Catalog Number: B9743

Z-1203-2022
Recall number
Z-1203-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
150 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2031128 2130202 2131304 UDI: 00849233011649

Distribution pattern

Nationwide

device · product 58 of 58

SS 4.5MM Pellet Insertion Tray Catalog Number: B9807

Z-1204-2022
Recall number
Z-1204-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Quantity
50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Code information

Lot Numbers: 2031228 UDI: 00849233003552

Distribution pattern

Nationwide