Angiodynamics Recalls XCELA PICC Kits Due to Bacterial Endotoxins
Angiodynamics Inc. is recalling 17 boxes of CAN 5F SINGLE XCELA PICC kits because a component may contain unsafe levels of bacterial endotoxins.
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 recall is classified as FDA Class II, and the presence of unsafe levels of bacterial endotoxins in a medical device poses a risk of significant injury, meeting the criteria for a Severe rating.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 17 boxes of CAN 5F SINGLE XCELA PICC kits, Catalog Number 60M701531. The recall was initiated because a component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
The affected products were distributed to 33 U.S. states, the District of Columbia, and four foreign countries: Canada, China, Ireland, and Spain. The specific U.S. states include AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV.
Healthcare providers and consumers should check their inventory for the specific lot numbers 5299826 and 5312185, or the UPN H96560M7015311. If these products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — PICC Line
- Hazard
- Affected units
- 17
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 (3)
- UPN: H96560M7015311
- Lot: 5299826
- 5312185
Distribution
Part of a larger recall action
This product is one of 38 recalled by Angiodynamics Inc. (Navilyst Medical 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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