Reported Nov 15, 2017 · Completed

Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture…

Bioseal Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bioseal Corporation · 167 W Orangethorpe Ave · Placentia, CA · 92870-6922

Is this the product you have?

  • Custom surgical kits labeled as follows
    • (a) Suture Removal Set
    • 910-0002 (b) Instrument Set
    • INST03/20 (c) Suture Removal Set
    • SUT309/100 (d) Incision & Drainage Tray
    • INC03/20 (e) Suture Removal Set
    • SUT103/50 (f) General Purpose Tray
    • GPT010/25 (g) General Purpose Tray
    • GPT002/50
Lot codes and dates
  • Lot Numbers
    • (a) 910-0002: 400348
    • 400354
    • 400364
    • 400370
    • 400386 (b)
  • INST03/20
    • 400349
    • 400354
    • 400361
    • 400364
    • 400366
    • 400367
    • 400370
    • 400372
    • 400373
    • 400380
    • 400386
    • 400392
    • 400393
    • 400393
    • 400396
    • 400396
    • 400399
    • 400401
    • 400403
    • 400414
    • 400416
    • 400417
    • 400419
    • 400422
    • 400427 (c)
  • SUT309/100
    • 400346
    • 400354
    • 400361
    • 400364
    • 400366
    • 400370
    • 400373
    • 400396
    • 400397
    • 400403
    • 400407
    • 400408
    • 400413
    • 400430
    • 400354
    • 400361
    • 400370
    • 400373
    • 400407
    • 400408
    • 400413
    • 400370
    • 400396
    • 400408
    • 400430
    • 400346
    • 400354
    • 400361
    • 400362
    • 400364
    • 400370
    • 400397
    • 400373
    • 400396
    • 400397
    • 400403
    • 400407
    • 400408
    • 400413
    • 400427
    • 400430
    • 400354 (d)
  • INC03/201137 (e)
  • SUT103/50
    • 400413
    • 400413
    • 400413
    • 400416
    • 400430
    • 400396
    • 400396
    • 400401
    • 400402
    • 400403
    • 400416 (f)
  • GPT010/25
    • 400348
    • 400351
    • 400355
    • 400364
    • 400369
    • 400376
    • 400385
    • 400389
    • 400395
    • 400402
    • 400414
    • 400422 (g)
  • GPT002/50
    • 400348
    • 400356
    • 400361
    • 400364
    • 400376
    • 400380
    • 400393
    • 400394
    • 400399
    • 400402
    • 400407
    • 400418
    • 400422
    • 400422
    • 400430
Amount recalled
51635 units

Where it was sold

Why it was recalled

Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.