Surgical extremity packs recalled after being labeled sterile without sterilization
Medline is recalling 88 Extremity Pack convenience kits that were labeled as sterile but never went through the sterilization process.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
Sterile Medline convenience kits sold as EXTREMITY PACK, model number DYNJ45701B, are being recalled because kits labeled as sterile have not gone through the sterilization process.
The recall covers 88 units from lot number 25GBF686, carrying UDI-DI 10193489856279 for each unit and 40193489856270 for the case. The product was distributed in Florida, Maryland, New Jersey and Tennessee. The FDA has classified the recall as Class I.
Because the packs are intended for use in a sterile field, hospitals and surgery centres holding the listed lot should quarantine it immediately, treat any remaining stock as non-sterile regardless of what the label says, and follow Medline's instructions.
The recalled product
- Product
- Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical kit
- Affected units
- 88
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)
- 1) DYNJ45701B
- UDI-DI: 10193489856279(each)
- 40193489856270(case)
- Lot Number: 25GBF686
Distribution
Part of a larger recall action
This product is one of 2 recalled by Medline Industries, LP 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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