Surgical Convenience Kits Recalled for Compromised Sterility Assurance
Medline Industries is recalling surgical convenience kits with reorder number DYNJCD0063 due to a perforated bag that fails to keep the kit's outer wrapping sterile. Affected units were distributed nationwide.
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: This is a Class II medical device recall involving a sterility assurance defect on surgical kits. No illnesses, injuries, or hospitalizations have been reported in the source text. The hazard is a risk-of-harm situation where the theoretical potential for contamination exists, but actual harm has not been documented.
Plain-English summary
Medline Industries, LP is recalling surgical convenience kits labeled as MEDLINE ARM/MINOR DRAPE CSTM with reorder number DYNJCD0063. The recalled lot number is 22GBF090. These kits were distributed nationwide.
The recall is due to a defect in the kit's perforated bag. The bag does not prevent the outer wrapping of the kit from becoming contaminated, meaning only the contents inside the kit wrapping maintain sterility. The external surfaces of the kit packaging cannot be relied upon to remain sterile, which creates a potential contamination risk during surgical preparation.
Healthcare facilities and end users with affected kits should discontinue use immediately and contact Medline Industries or their authorized distributor for instructions regarding return or replacement. Do not use these kits for surgical procedures.
The recalled product
- Product
- Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
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)
- Reorder Number DYNJCD0063
- GTIN 40884389462011
- Lot # 22GBF090
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by MEDLINE INDUSTRIES, LP - Northfield 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.
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