Kerlix AMD Antimicrobial Bandage Roll Recalled for Sterility Breach Risk
Coviden LLC is recalling Kerlix AMD Antimicrobial Bandage Rolls due to a potential seal defect that could compromise product sterility.
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 is a potential sterility breach, which poses a risk of harm (infection) but no injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Coviden LLC is recalling 2,730,821 units of Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332. The recall is due to a potential for product sterility breach caused by a compromised or pinched seal defect. The product is used as both a primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization and penetration.
The affected units were distributed nationwide in the United States. The specific lot numbers involved in this recall are: 18D180962, 18D181062, 18E029462, 18E029562, 18E070762, 18E131262, 18E131362, 18E131462, 18E166662, 18E167362, 18E223462, 18E223362, 18F054362, 18E222662, 18F034762, 18F034662, 18F035562, 18F072862, 18F072662, 18F072962, 18F123062, 18F122562, and 18F122662.
Healthcare providers and consumers should check their inventory for these specific lot numbers. If the product is found, it should be removed from use and returned to the supplier or Coviden LLC according to their instructions. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the…
- Manufacturer
- COVIDIEN LLC
- Category
- Medical Device — Wound Care
- Affected units
- 2,730,821
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: 18D180962
- 18D181062
- 18E029462
- 18E029562
- 18E070762
- 18E131262
- 18E131362
- 18E131462
- 18E166662
- 18E167362
- 18E223462
- 18E223362
- 18F054362
- 18E222662
- 18F034762
- 18F034662
- 18F035562
- 18F072862
- 18F072662
- 18F072962
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by COVIDIEN LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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