Customed Recalls PERl GYN PACK Surgical Kits Due to Packaging Integrity Concerns
Customed, Inc. is recalling 43 lots of PERl GYN PACK surgical kits because packaging integrity may be compromised, potentially leading to loss of sterility.
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: The recall involves a risk-of-harm product (loss of sterility/contamination) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Customed, Inc. has initiated a recall of 43 lots of PERl GYN PACK surgical kits, totaling 3,201 units. The recall involves multiple catalog numbers and specific lot codes ranging from 110051144 to 140513473. The affected products are EO sterilized surgical convenient packs packaged in polyester/polyethylene breather bags with Tyvek double vents.
The recall was issued because Customed determined there is a possibility that packaging integrity may be compromised on these lots. This defect could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients using the devices.
The affected products were distributed worldwide, including nationwide in the United States (specifically noting Florida, Puerto Rico, and the US Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Users of these medical devices should check their inventory against the listed lot codes and contact Customed, Inc. for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- PERl GYN PACK- (1) DRAPE UTILITY WITH TAPE UF (2) TOWELS ABSORBENT 15" X 20" UF (1) TOP DRAPE WITH ADHESIVE STD SMS (1) CATHETER NELATON ROB. 14FR. (2) GOWN IMPERVIOUS EXTRA REINFORCED XL (1) UNDERBUITOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" X 42" (1) TABLE COV
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Kits
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 (1)
- Product code 900-1061
Distribution
Part of a larger recall action
This product is one of 233 recalled by Customed, Inc 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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