FDAClass IIOctober 10, 2018

Kerlix Bandage Roll recall: Sterility Concern

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…

Why was Kerlix Bandage Roll recalled?

Potential for product sterility breach due to a compromised or pinched seal defect

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 18D181262,18D181162,18E029662,18E029762,18E029862, 18E029962,18E030062,18E030162,18E030262,18E030362, 18E070962,18E071062,18E071162,18E071262,18E071362, 18E071462,18E071562,18E071662,18E131562,18E131962, 18E132062,18E132162,18E131662,18E131762,18E131862, 18E166762,18E167462,18E166862,18E166962,18E167562, 18E167162,18E167062,18E167762,18E167662,18E167262, 18E222762,18E223162,18E223062,18E222962,18E222862, 18E223662,18E223562,18E224062,18E223962,18E223862, 18E223762,18F035862,18F034962,18F034862,18F035262, 18F035162,18F035062,18F035362,18F035962,18F035762, 18F035462,18F089262,18F036262,18F036162,18F036062, 18F073062,18F072762,18F123262,18F123162,18F158462, 18F158362,18G004562

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…
Recalling firm
COVIDIEN LLC
Quantity
2,730,821 units in total
Distribution
US Nationwide Distribution
Recall date
October 10, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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