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.
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 product (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential 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 LI
- 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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