PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Reported: February 17, 2021 Initiated: January 4, 2021 #Z-1065-2021
Product Description
PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Reason for Recall
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Details
- Recalling Firm
- Aomori Olympus Co., Ltd.
- Units Affected
- 7,400,000 (globally); 260,395 (US)
- Distribution
- US Nationwide distribution.
- Location
- Kuroishi, N/A
Frequently Asked Questions
What product was recalled? ▼
PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.. Recalled by Aomori Olympus Co., Ltd.. Units affected: 7,400,000 (globally); 260,395 (US).
Why was this product recalled? ▼
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 17, 2021. Severity: Moderate. Recall number: Z-1065-2021.
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