FDA Device recall Z-0830-2018
Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric…
- FDA Device
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric… by Cook, citing cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0830-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-19 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cook |
| Distribution | US |
Product
Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Reason
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
Identifiers
| code_info | WOGS-1400 -MKOT-A Lot numbers: 6869315 6908857 7034661 7106057 7193431 7252317 7635697 7744001 7811587 8025220 8076495 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0830-2018%22
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