Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Reported: March 7, 2018 Initiated: October 19, 2017 #Z-0830-2018
Product Description
Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Reason for Recall
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
Details
- Recalling Firm
- Cook Inc.
- Units Affected
- 615
- Distribution
- US Nationwide Distribution
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding. Recalled by Cook Inc.. Units affected: 615.
Why was this product recalled? ▼
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 7, 2018. Severity: Moderate. Recall number: Z-0830-2018.
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