Andover Healthcare Recalls Sterile Co-Flex LF2 Wound Dressings Due to Seal Defects
Andover Healthcare Inc. is recalling 330 cases of Sterile Co-Flex LF2 3" 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 involves a sterile medical device with a defect that compromises sterility, posing a risk of infection or harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Andover Healthcare Inc. is recalling 330 cases of Sterile Co-Flex LF2 3" single-use secondary wound dressings or compression wraps. The recall was initiated due to incomplete packaging seals on the sterile product, which could potentially affect the sterility of the device.
The affected products are identified by Manufacturer's Catalog # 9300S. The expiration dates range from October 1, 2021, to June 14, 2022. The specific lot numbers involved are CIOZJV, CI02SW, CI18YA, and CI1FJ2.
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 providers should stop using these products and contact Andover Healthcare Inc. for instructions on return or replacement.
The recalled product
- Product
- Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or compression wrap
- Manufacturer
- Andover Healthcare Inc.
- Category
- Medical Device — Wound Dressing
- Affected units
- 330
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 (3)
- CI02SW
- CI18YA
- CI1FJ2
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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