Customed Recalls Angiodrape Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 180 units of Angiodrape Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric, as it represents a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Customed, Inc. is recalling 180 units of Angiodrape Packs (Product code 900-366) across five specific lots. The recall is due to a determination that packaging integrity may be compromised on these items. The affected lots are 113026100, 113057477, 113078475, 113088811, and 113109832.
The compromised packaging 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.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected Angiodrape Packs. Consumers are not expected to have these medical devices in their homes, but if they do, they should contact their healthcare provider or the recalling firm for instructions.
The recalled product
- Product
- ANGIODRAPE PACK - - (1) GUIDEWIRE 0.035" X 150cm (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK UF (2) Pr. SURGICAL GLOVES #8 (2) GOWN STANDARD LARGE SMS VELCRO NECK (2) NEEDLE HYPODERMIC 21G X 1 W' UF (1) TABLE COVER 44" X 90" (3) CLOTH HUCK TOWELS BLUE (2) UTILITY BOWL 16oz
- 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 (2)
- Product code 900-366
- 5 lots: 113026100 113057477 113078475 113088811 113109832
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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