Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 1,041 units of EO sterilized surgical convenient packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I. Per the rubric, FDA Class I recalls are assigned a severity score of 5 (Critical).
Plain-English summary
Customed, Inc. is recalling 1,041 units of EO sterilized surgical convenient packs, identified by product code 900-741, across 16 specific lots. The recall involves multiple catalog numbers and items such as gowns, cautery tips, surgical solutions, and gloves. The affected products are 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 the affected lots. This defect could result in an injury to the patient due to product contamination or a loss of the sterility condition. The agency has classified this recall as Class I.
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 the affected products and contact Customed, Inc. for further instructions or a return.
The recalled product
- Product
- IMPLANTE DE ORTHOPEDIA- 1) GOWN IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV (1) CAUTERY TIP POLISHER LIF (1) DURAPREP SURGICAL SOLUTION 26ml LIF (1) BAG SUTURE FLORAL LIF (1) TUBE SUCTION CONNECT. Y.!" X 12' L/F (1) CAUTERY PENCIL ROCKER SWITCH LIF (2) *Pr. SURGEON…
- 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 900-741
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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