Medline Knee Arthroscopy Kit Recalled for Expired Irrigation Component
Medline Industries is recalling 286 knee arthroscopy kits containing an expired NaCl irrigation bag. The kits should not be used due to the expired component.
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: FDA Class II recall involving surgical equipment with a potentially compromised component. While no illnesses or injuries have been reported, this represents a risk-of-harm product used in invasive procedures where sterility is critical.
Plain-English summary
Medline Industries Inc is recalling 286 Knee Arthroscopy Kits (REF DYNJ902838C, Lot 19WBA897) that contain an expired irrigation component. The kits include NaCl 3000mL Irrigation Bags with an expiration date of August 1, 2020. These convenience kits were distributed nationwide in Minnesota, Nebraska, and Pennsylvania.
The FDA classified this as a Class II recall. The expired irrigation solution may not maintain appropriate sterility for surgical use.
Healthcare facilities and professionals who have received these kits should stop using them immediately and discontinue their use. Patients or healthcare providers with questions about this recall or who have already used one of the affected kits should contact Medline Industries Inc or the FDA.
The recalled product
- Product
- Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
- Manufacturer
- Medline Industries Inc
- Hazard
- expired-component
- contamination-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 (3)
- Lot 19WBA897
- Exp. 2020-12-31
- GTIN (01)10193489225143.
Distribution
Distributed nationwide across the United States.
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