Customed Recalls Endovascular Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Endovascular Packs (code 900-2715) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies the agency classification as 'Class I'. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical), as it indicates a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Customed, Inc. is recalling Endovascular Packs, code 900-2715, due to a potential compromise in packaging integrity. The recall involves one lot (113099591) consisting of 12 units. The company determined that the packaging may not be fully intact, which could result in product contamination or a loss of the sterile condition required for these medical devices.
The affected products are EO sterilized surgical convenient packs packaged in polyester/polyethylene breather bags with Tyvek double vents. The distribution pattern for this lot was worldwide, including the United States (nationwide, specifically Florida, Puerto Rico, and USVI) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.
Healthcare facilities and consumers who have purchased or received these specific Endovascular Packs should stop using them immediately. Users should contact Customed, Inc. for instructions on how to return the product or obtain a replacement. The FDA has classified this recall as Class I, indicating a reasonable probability that the use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Endovascular Pack, code 900-2715, contains: ( I) DRAPE FEMORAL ANG. 125 X 75 X 56 WITH POUCH LIF (2) TOWELS ABSORBENT 15 X 20 LIF ( I) CONTAINER SPECIMEN 4oz W/LID & LABEL Llf (2) BAG BAND FLUOROSCOPE 36 X 30 LIF ( I) NEEDLE HYPODERMIC 21G X I Y, LIF (2) GOWN LARGE SMS IMPE
- 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)
- Code 900-2715
- 1 lot: 113099591
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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