Surgical Convenience Kits Recalled Due to Included 3M Surgical Drapes
Surgical convenience kits are being recalled because they contained 3M surgical drapes that were subsequently recalled. 177 kits distributed in Louisiana, Missouri, North Carolina, and Florida are affected.
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: Class II medical device recall of a surgical product containing a recalled component with no reported illnesses or injuries. Surgical kits qualify as risk-of-harm products where injury has not yet been reported, per the rubric.
Plain-English summary
ROi CPS LLC is recalling 177 regard SHOULDER PACK (GS00125V, Item Number 880120022) surgical convenience kits. The recall is being issued because the kits contain 3M surgical drapes that were subsequently recalled. The affected kits have UDI/DI 10194717114536, Lot Number 92275 with an expiration date of April 22, 2024.
The kits were distributed in Louisiana, Missouri, North Carolina, and Florida.
The recalled product
- Product
- regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kit
- Manufacturer
- ROi CPS LLC
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 10194717114536
- Lot Numbers: 92275
- exp 4/22/2024
Distribution
Distributed in 4 states:
- FL
- LA
- MO
- NC
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