Hydrocolloid Bandage Recall: Potential Sterility Compromise in Multiple Models
Medline Industries recalls Wayson Hydrocolloid bandages due to potential compromise of device sterility. Approximately 364,842 units across five model numbers are affected.
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: This is classified as FDA Class II. While no reported illnesses or injuries are mentioned, the hazard (potential sterility compromise) represents a risk-of-harm scenario for a medical device applied directly to wounds. Per the rubric, risk-of-harm products where injury has not yet been reported score as 'High' (3).
Plain-English summary
Medline Industries, LP is recalling Wayson Hydrocolloid bandages across five model numbers: CUR5103, MJ18004, MJ18005, MJ76126V1, and RA0353818V1. Approximately 364,842 units are affected by this recall.
The FDA has determined there is a potential for the sterility of these devices to be compromised. These are hydrocolloid bandages intended for wound and blister care.
The recalled products were distributed worldwide, including throughout the United States and to Bermuda, Canada, Panama, and Singapore. Specific lot numbers for each model have been identified by the manufacturer.
The recalled product
- Product
- Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93", 2) Model Number: MJ18004, DBD-MEIJER,BANDAGE,HYDROCOLLOID,HEEL,OVL 3) Model Number: MJ18005, MEIJER,BANDAGE,HYDROCOLLOID,ALLPURP,10CT 4) Model Number: MJ76126V1, DBD-MEIJER,HYDROCOL
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-compromise
- infection-risk
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 (20)
- 1) CUR5103
- UDI-DI: 00888277307400(each)
- 40888277307408(case)
- Lot Number: 10315040001
- 2) CUR5103
- Lot Number: 10317020005
- 3) CUR5103
- Lot Number: 10317030004
- 4) CUR5103
- Lot Number: 10317120001
- 5) CUR5103
- Lot Number: 10318050003
- 6) CUR5103
- Lot Number: 10318070002
- 7) CUR5103
- Lot Number: 10318080003
- 8) CUR5103
- Lot Number: 10319010004
- 9) CUR5103
- Lot Number: 10319050004
Distribution
Distributed nationwide across the United States.
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