Medline Pre-Op Kits Recalled for Potential Sterility Breach
Medline is recalling 13,032 pre-operative kits nationwide due to packaging defects that may compromise sterility, posing a risk of microbial contamination.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (microbial contamination and potential infection) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Medline Industries, LP is recalling 13,032 pre-operative convenience kits distributed nationwide. The affected products include various Pre-Op Kits, Cataract Preop Kits, and General Preop Kits, identified by specific catalog numbers and lot numbers listed in the recall documentation.
The recall is due to a potential breach of sterility in the packaging of the BD ChloraPrep Clear and FREPP Clear applicators contained within the kits. Wrinkles in the paper lidding may extend to the seal area, compromising the sterile barrier. If the barrier is compromised, patients and users may be exposed to microbial contamination.
Potential health consequences range from no injury to localized infection or more serious infections requiring medical treatment, antimicrobial therapy, or hospitalization. In rare cases, particularly for critically ill or immunocompromised patients, severe infection could become life-threatening. Consumers should check their inventory for the specific catalog and lot numbers listed in the official recall notice and contact Medline for instructions on returning or disposing of the affected kits.
The recalled product
- Product
- Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT, Catalog Number: DYKS1128C; 3) PRE OP KIT, Catalog Number: DYKS1216I; 4) PRE OP KIT, Catalog Number: DYKS1325A; 5) CATARACT PREOP KIT, Catalog Number: DYKS1583; 6) GENERAL PREOP KIT…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 13,032
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)
- 1) DYKS1043F
- UDI-DI: 10195327392086(each)
- 40195327392087(case)
- Lot Number: 23KBL520
- 2) DYKS1043F
- Lot Number: 23LBP488
- 3) DYKS1128C
- UDI-DI: 10195327549374(each)
- 40195327549375(case)
- Lot Number: 25ABQ496
- 4) DYKS1128C
- Lot Number: 24CBI654
- 5) DYKS1128C
- Lot Number: 24DBU596
- 6) DYKS1128C
- Lot Number: 24FBA388
- 7) DYKS1128C
- Lot Number: 24GBD436
- 8) DYKS1128C
- Lot Number: 24JBC974
Distribution
Distributed nationwide across the United States.
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