Kerlix Bandage Rolls Recalled for Potential Sterility Breach
COVIDIEN LLC is recalling Kerlix Bandage Rolls due to a seal defect that may compromise sterility. The recall covers 2,730,821 units distributed nationwide.
What this means for you
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 potential sterility breach, which is a risk-of-harm product issue where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
COVIDIEN LLC is recalling Kerlix Bandage Rolls, 100% Cotton, 6 Ply, Large (REF 6715), due to a potential product sterility breach. The recall is caused by a compromised or pinched seal defect that may affect the sterility of the bandages.
The recall involves 2,730,821 units that were distributed nationwide in the United States. The affected lot numbers are listed in the agency's recall record. These products are used as both primary and secondary dressings for bandaging heads, limbs, and difficult-to-dress wounds.
Consumers should stop using the affected bandage rolls and contact COVIDIEN LLC for instructions on how to return the product or obtain a replacement. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
- 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: 18D181262
- 18D181162
- 18E029662
- 18E029762
- 18E029862
- 18E029962
- 18E030062
- 18E030162
- 18E030262
- 18E030362
- 18E070962
- 18E071062
- 18E071162
- 18E071262
- 18E071362
- 18E071462
- 18E071562
- 18E071662
- 18E131562
- 18E131962
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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