Customed Recalls Femoral Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 855 units of Customed Femoral Packs because packaging integrity may be compromised, potentially leading to loss of sterility or patient injury.
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 injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Customed, Inc. is recalling 855 units of Customed Femoral Packs, a convenience pack containing multiple surgical components such as syringes, needles, gauze, and drapes. The recall affects 14 specific lots of the product, which is EO sterilized and packaged in a polyester/polyethylene breather bag with Tyvek double vents.
The recall was initiated because the company determined that 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 a loss of sterility condition.
The affected products were distributed worldwide, including nationwide in the United States (specifically mentioning 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
- Customed Femoral Pack , convenience pack include multiple components: Syringe 3cc, 5cc, 10cc, 20cc; swabstick chlorascrub, needles, gauze/sponges, table cover, absrobent towels, halsted Mosquito CVD, gown, bowls, wrapper, scalpel safety, Mosquito forcep, cloth huck, clamp towel,
- 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 900-164
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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