Andover Healthcare Recalls Sterile Co-Flex Med Wound Dressings
Andover Healthcare Inc. is recalling 269 cases of Sterile Co-Flex Med 3" wound dressings due to 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 involves a sterile medical device with a defect that compromises sterility, posing a risk of infection (risk-of-harm product) without reported injuries, which aligns with the 'High' severity criteria.
Plain-English summary
Andover Healthcare Inc. is recalling 269 cases of Sterile Co-Flex Med 3" single-use secondary wound dressings or compression wraps. The recall is due to incomplete packaging seals, which may compromise the sterility of the product.
The affected products have a manufacturer's catalog number of 7300S and an expiration date range of October 1, 2021, to June 14, 2022. The specific lot number is CI10LN. The products were distributed nationwide in the United States, including Massachusetts, Texas, Rhode Island, Ohio, New York, Minnesota, South Dakota, Illinois, Missouri, Florida, Virginia, Nebraska, Utah, and California.
Consumers and healthcare facilities should stop using the affected products and contact Andover Healthcare Inc. for further instructions or a refund.
The recalled product
- Product
- Sterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing or compression wrap
- Manufacturer
- Andover Healthcare Inc.
- Category
- Medical Device — Wound Dressing
- Affected units
- 269
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
Same manufacturer · Andover Healthcare Inc.
See all →- HighCoFlex NL Sterile Bandages Recalled for Packaging Seal Gaps
FDA (Devices) · 2024-05-22
- HighAndover Healthcare Recalls Sterile Co-Flex NL Wound Dressings Due to Packaging Defect
FDA (Devices) · 2019-10-30
- HighAndover Healthcare Recalls Sterile Co-Flex NL Wound Dressings Due to Packaging Seal Issues
FDA (Devices) · 2019-10-30
- ModerateAndover Healthcare Recalls Sterile Co-Flex Med Wound Dressings Due to Packaging Seal Defects
FDA (Devices) · 2019-10-30
- HighAndover Healthcare Recalls Sterile Co-Flex LF2 Wound Dressings Due to Seal Defects
FDA (Devices) · 2019-10-30
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