Andover Healthcare Recalls Sterile Co-Flex NL Wound Dressings Due to Packaging Seal Issues
Andover Healthcare Inc. is recalling 1,798 cases of sterile Co-Flex NL 3-inch wound dressings because of incomplete packaging seals that may compromise 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 and involves a sterile medical device where compromised packaging could lead to infection, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Andover Healthcare Inc. is recalling 1,798 cases of Sterile Co-Flex NL 3-inch secondary wound dressings or compression wraps. The recall was initiated due to incomplete packaging seals on the sterile products. The affected products were distributed nationwide, including in Massachusetts, Texas, Rhode Island, Ohio, New York, Minnesota, South Dakota, Illinois, Missouri, Florida, Virginia, Nebraska, Utah, and California.
The affected products have a catalog number of 5300S and expiration dates ranging from October 1, 2021, to June 14, 2022. Specific lot numbers involved in the recall include CI0ST7, CI0ZJT, CI17BA, CI18Y6, and CI1HM0. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare facilities should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to the recall instructions. No specific instructions for consumer disposal are provided in the source text, but standard medical waste protocols for compromised sterile items should be followed.
The recalled product
- Product
- Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap.
- Manufacturer
- Andover Healthcare Inc.
- Category
- Medical Device — Wound Care
- Affected units
- 1,798
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 (4)
- CI0ZJT
- CI17BA
- CI18Y6
- CI1HM0
Distribution
Part of a larger recall action
This product is one of 6 recalled by Andover Healthcare Inc. 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.
See all 6 products in this recall →Related recalls
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