The Recall Desk
HighFDA (Devices)·Z-0309-2023·Announced 2022-11-30

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
Category
Medical Device — Surgical Supplies
Affected units
177

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:

Part of a larger recall action

This product is one of 40 recalled by ROi CPS LLC 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.

See all 40 products in this recall →

Related recalls

Same manufacturer · ROi CPS LLC

See all →