Customed Recalls Angiography Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 570 units of angiography 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility…"
Plain-English summary
Customed, Inc. is recalling 570 units of angiography packs (product code 900-1488) across 16 lots. The recall is due to the 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 loss of sterility condition.
The affected products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents. The distribution pattern includes worldwide distribution, specifically the United States (nationwide) including Florida, Puerto Rico, and the US Virgin Islands (St. John), as well as the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice. Users should verify the lot numbers of their products against the list provided in the recall documentation to determine if they are affected.
The recalled product
- Product
- ANGIOGRAPHY PACK - (1) LINE H.P. 1200 PSI 48" M/F (1) ANG. FEMORAL DRAPE WITH POUCH UF (1) PLATFORM TRAY LARGE (3) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) BAG BAND RUBBAN & TAPE UF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK…
- 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 900-1488
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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