UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary pack
FDA device recall Z-0861-2015 · posted 2014-12-23 · Terminated
Recall details
- Recalling firm
- US Endoscopy Group Inc
- Reason for recall
- Packaging non-conformance related to the integrity of the sterile pouch seal.
- Action taken
- Consignees were notified by phone, e-mail, and an Urgent: US Endoscopy UroSeal Adjustable Valve Recall letter. The letter identified the affected product and the reason for the recall. Customers were asked to remove any affected product from their inventory and quarantine them. Additionally, customers were to complete and return the attached Customer Response Card to Kia Pennington via fax at 1-440-639-4495 or e-mail at recall@usendoscopy.com as soon as possible. The firm contacted customers regarding the RMA instructions and replacement product. Customers were to follow the RMA instructions in order to receive an RMA number and return the affected product. Questions should be directed towards Kia Pennington in Customer Service at 1-800-769-8229.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- KOG
- Quantity affected
- 100 units
- Distribution
- Distributed to the states of FL, MO, OH and WI.
- Date initiated
- 2014-10-31
- Date posted
- 2014-12-23
- Date terminated
- 2015-06-01
- Location
- Mentor, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 (K070420) | United States Endoscopy Group, Inc. | 2007-03-19 |