Stradis Healthcare Surgical Knee Packs Recalled for Incomplete Sealing
HENRY SCHEIN Knee Packs are being recalled due to incomplete outer bag sealing that may breach sterility. Affected surgical kits were distributed in the US and Canada.
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: FDA Class II recall involving a sterility breach in surgical procedure kits. Although no illnesses have been reported, the incomplete sealing presents a theoretical risk of contamination during medical procedures, which meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Stradis Medical, LLC, doing business as Stradis Healthcare, is recalling HENRY SCHEIN Knee Packs (Item No. 570-2908). Medical and surgical procedure kits in this recall underwent certain manufacturing conditions that resulted in incompletely sealed outer bags.
The incomplete sealing may result in a breach in the sterility of the kit. The recalled kits were distributed nationwide in the United States and Canada, with lot number 22241489773.
Compromised sterility in surgical procedure kits creates a risk of contamination during medical and surgical procedures. Healthcare facilities should verify whether they have received affected units.
The recalled product
- Product
- HENRY SCHEIN, Knee Pack, Item No.570-2908,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Category
- Medical Device — Surgical Kit
- Affected units
- 48
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)
- UDI/DI (case) H65857029081
- UDI/DI (kit)M75257029080
- Serial/Lot Numbers: 22241489773
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 78 recalled by Stradis Medical, LLC dba Stradis Healthcare 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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