Customed Recalls Pery Gyn Pack Surgical Kits Due to Packaging Integrity Concerns
Customed, Inc. is recalling Pery Gyn Pack surgical kits because packaging integrity may be compromised, potentially leading to product contamination or 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 (sterile surgical kits) where injury has not yet been reported, fitting the High severity criteria for potential contamination or loss of sterility.
Plain-English summary
Customed, Inc. is recalling Pery Gyn Pack surgical kits, which contain various sterile surgical supplies such as table covers, drapes, towels, gowns, and catheters. The recall involves two specific lots of the product, identified by codes 140312022 and 140412694, with a total of 48 units affected.
The company determined that there is a possibility that the packaging integrity of these kits may be compromised. This defect could result in product contamination or a loss of the sterile condition, which poses a risk of injury to patients using the products.
The affected products were distributed worldwide, including nationwide in the United States (specifically Florida, Puerto Rico, and the US Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Healthcare facilities and consumers should check their inventory for the specific lot numbers listed and stop using the affected products if found.
The recalled product
- Product
- PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) DRAPE UTILITY (2) TOWELS ABSORBENT 15" X 20" (1) GOWN XL SMS IMPERV. REINF. AAMI LEVEL Ill (1) DRAPE UNDERBUTIOCK W/POUCH 44" X 35" (1) TIME OUT BEACON NON WOVEN (1) BOWL UTILITY BLUE 16oz (1) BAG SUTURE FLORA
- 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 (2)
- Product code 900-548A
- 2 lots: 140312022 140412694
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.
See all 233 products in this recall →Related recalls
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