Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183
Reported: July 12, 2023 Initiated: May 30, 2023 #Z-2090-2023
Product Description
Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183
Reason for Recall
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Details
- Recalling Firm
- DeRoyal Industries Inc
- Units Affected
- 306 packs
- Distribution
- US Nationwide distribution.
- Location
- Powell, TN
Frequently Asked Questions
What product was recalled? ▼
Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183. Recalled by DeRoyal Industries Inc. Units affected: 306 packs.
Why was this product recalled? ▼
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 12, 2023. Severity: Moderate. Recall number: Z-2090-2023.
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