U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for
FDA device recall Z-0355-2016 · posted 2015-12-01 · Terminated
Recall details
- Recalling firm
- Procedure Products, Inc.
- Reason for recall
- The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle
- Action taken
- The firm sent the Urgent Medical Device Recall letter to their consignees via email on 10/27/15. Customers with questions can call Doug Rowley at 360-693-1832 or send email to doug@procedureproducts.com
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DRE
- Quantity affected
- 1100 pieces
- Distribution
- Distributed in the states of MT and NY.
- Date initiated
- 2015-10-27
- Date posted
- 2015-12-01
- Date terminated
- 2016-04-01
- Location
- Vancouver, WA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SINGLE USE SELDINGER/COURNAND PERC. NDL (K810859) | Procedure Products, Inc. | 1981-04-11 |