The Recall Desk
ModerateFDA (Devices)·Z-2233-2021·Announced 2021-08-18

Medline Total Knee Surgical Kit Recalled for Expired Irrigation Component

Medline Industries is recalling Total Knee convenience kits that may contain an expired saline irrigation solution component. The expired component may not maintain proper sterility for surgical use.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is precautionary in nature—an expired sterile component may compromise sterility, but no actual harm has been reported. This meets the criteria for a moderate-severity voluntary precautionary recall.

Plain-English summary

Medline Industries Inc is recalling Total Knee convenience kits (REF DYNJ907129B) because they may contain an expired NaCl 3000mL Irrigation Bag component that expired on August 1, 2020. A total of 286 kits have been identified in this recall.

The expired irrigation solution component may not maintain proper sterility, which is critical for use during open surgical procedures. The kits were distributed nationwide in Minnesota, Nebraska, and Pennsylvania.

Consumers and healthcare facilities should stop using affected kits immediately and contact Medline Industries for return or replacement instructions. The affected lot is 20LBF040 with an expiration date of December 31, 2021.

The recalled product

Product
Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Manufacturer
Medline Industries Inc
Hazard
  • expired-component
  • contamination

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)

  • Lot 20LBF040
  • Exp. 2021-12-31
  • GTIN (01)10193489443615.

Distribution

Distributed nationwide across the United States.