Customed Recalls Plastic Surgery Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling plastic surgery packs 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 (loss of sterility/contamination) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Customed, Inc. is recalling specific lots of Plastic Surgery Packs. The recall involves 21 lots totaling 680 units. The affected products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents.
The recall was initiated because Customed determined there is a possibility that packaging integrity may be compromised on different catalog numbers. This defect could result in an injury to the patient due to product contamination or loss of sterility condition.
The affected products were distributed worldwide, including nationwide in the United States (specifically Florida, Puerto Rico, and USVI) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Consumers and healthcare facilities should stop using these products and contact Customed, Inc. for further instructions.
The recalled product
- Product
- PLASTIC SURGERY PACK- (1) MAYO STAND COVER REINFORCED LIF (1) CAUTERY TIP POLISHER LIF (1) BAG SUTURE FLORAL L/F (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (20) GAUZE SPONGES 4" X 4" 4PL Y (1) COVER TABLE REINFORCED 50" X 90" LIF (2) GOWN IMPERVIOUS REINFORCED LARGE SMS
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
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 900-920
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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