Customed Recalls Universal Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Universal Packs containing surgical items due to potential packaging integrity issues that could compromise 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 (injury due to contamination or loss of sterility) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Customed, Inc. is recalling Universal Packs, which contain various surgical items such as table covers, towels, suction tubes, and drapes. The recall involves 8 lots and 120 units of the product, identified by product code 900-169.
The recall was initiated because Customed determined there is a possibility that the packaging integrity may be compromised. This defect could result in product contamination or a loss of sterility, which poses a risk of injury to patients.
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. Consumers and healthcare facilities should stop using these products and contact the manufacturer for further instructions.
The recalled product
- Product
- Universal Pack- - (1) TABLE COVER REINFORCED 50" X 90" LIF (3) TOWEL ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) TUBE SUCTION CONNECT. X" X 12' LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) BAG SUTURE FLORAL (1) DRAPE TOP WITH ADHESIVE 100" X 53"
- 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 900-169
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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