Bioseal Custom Surgical Kits Recalled for Expired Iodine Prep Pads
Bioseal Corporation is recalling custom surgical kits containing Aplicare Providone Iodine Prep Pads due to incorrect expiration dates.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (incorrect expiration date) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Bioseal Corporation is recalling 51,635 units of custom surgical kits. The affected products include Suture Removal Sets, Instrument Sets, Incision & Drainage Trays, and General Purpose Trays. These kits contain Aplicare Providone Iodine Prep Pads that were previously recalled by Medline Industries because of incorrect expiration dates.
The recall covers specific lot numbers for each kit type, including 910-0002, INST03/20, SUT309/100, INC03/20, SUT103/50, GPT010/25, and GPT002/50. The products were distributed in California, Illinois, North Carolina, and Vermont.
Healthcare facilities and consumers should stop using these kits and contact Bioseal Corporation for instructions on returning the affected products.
The recalled product
- Product
- 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…
- Manufacturer
- Bioseal Corporation
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 51,635
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Numbers: (a) 910-0002: 400348
- 400354
- 400364
- 400370
- 400386 (b) INST03/20: 400349
- 400361
- 400366
- 400367
- 400372
- 400373
- 400380
- 400386
- 400392
- 400393
- 400396
- 400399
- 400401
- 400403
- 400414
- 400416
Distribution
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