Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal… — Class II medical device recall Z-0708-2017
Terminated recall by Angiodynamics Inc. (Navilyst Medical Inc.), reported 2016-12-14, distributed nationwide. Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the M
| Recall number | Z-0708-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Angiodynamics Inc. (Navilyst Medical Inc.), Glens Falls, NY, United States |
| Recall initiated | 2016-08-29 |
| Classified | 2016-12-05 |
| Reported by FDA | 2016-12-14 |
| Terminated | 2018-06-15 |
| Distributed | Nationwide (US) |
| Reason classes | labeling, sterility |
| Lot numbers | 5056512, 505722 |
Product
Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media
Reason for recall
Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves supplied to Navilyst contain an incorrect expiration date. Navilyst has confirmed that Medlines affected sterile gloves (Medline Part Number MSG1075/MSG3075) have been included in a limited number of kits.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0708-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.