Kerlix Bandage Roll Recalled for Potential Sterility Breach
COVIDIEN LLC is recalling Kerlix Bandage Rolls due to a potential seal defect that could compromise product sterility.
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 involves a medical device with a potential sterility breach, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
COVIDIEN LLC is recalling Kerlix Bandage Rolls, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716. The recall involves 2,730,821 units distributed nationwide in the United States. The specific lot numbers affected are 18E071762, 18E072262, 18E072362, 18E132262, and 18E132362.
The recall was initiated due to a potential for product sterility breach caused by a compromised or pinched seal defect. These bandage rolls are used as both primary and secondary dressings for bandaging heads, limbs, and difficult-to-dress wounds.
Consumers and healthcare providers should check their inventory for the specific lot numbers listed above. If the product is found, it should be removed from use and returned to the supplier or the manufacturer for further instructions.
The recalled product
- Product
- Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
- Manufacturer
- COVIDIEN LLC
- 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 (5)
- Lot Numbers: 18E071762
- 18E072262
- 18E072362
- 18E132262
- 18E132362
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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