FDA Device recall Z-2293-2021
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference…
- FDA Device
- Class II
- ongoing
- Published 2021-08-25
On 2021-08-25 the FDA classified a Class II recall of Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference… by W L Gore And Associates, citing vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2293-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-05-12 |
| Published | 2021-08-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | W L Gore And Associates |
| Distribution | AZ, CA, DC, GA, IL, KY, MA, MD, NE, WA |
Product
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT060015 UDI: (01)00733132606368 HPT060015A UDI: (01)00733132606375
Reason
Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.
Identifiers
| code_info | Serial Number for HPT060015A: 6185496PP001 and Serial Numbers for HPT060015: 6185502PP001, 6185502PP002, 6185502PP003,…Serial Number for HPT060015A: 6185496PP001 and Serial Numbers for HPT060015: 6185502PP001, 6185502PP002, 6185502PP003, 6185502PP004, 6185502PP006, 6185502PP007, 6185502PP009, 6185502PP010, 6185503PP001, 6185503PP002, 6185503PP004, 6185503PP005, 6185503PP006, 6185503PP007, 6185503PP008, 6185503PP009, 6185503PP010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2293-2021%22
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