Customed Angiodrape Pack Recalled for Potential Packaging Integrity Issues
Customed, Inc. is recalling 1,536 units of Angiodrape Packs due to potential packaging integrity issues that could compromise sterility and risk patient injury.
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 FDA has classified this as a Class I recall, which is defined as a situation where use of or exposure to a violative product may cause serious adverse health consequences or death.
Plain-English summary
Customed, Inc. is recalling 26 lots of Customed Angiodrape Packs, totaling 1,536 units. These convenience packs contain multiple medical components, including syringes, gauze, needles, and drapes, which are EO sterilized and packaged in polyester/polyethylene breather bags with Tyvek double vents.
The recall was initiated because the company determined there is a possibility that packaging integrity may be compromised on different catalog numbers. This defect could result in product contamination or a loss of sterility condition, 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. The FDA has classified this as a Class I recall. Consumers and healthcare facilities should stop using these products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Customed Angiodrape Pack convenience pack include multiple components: syringe 10cc and 30cc, gauze, denture cup, specimen container, band bag, glove, gown, needle hypodermic, absorbent towels, table cover, scalpel,cloth huck towel,iodine povidone,applicator sponge,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 900-002
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.
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