Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long, with X Coating The Sa
FDA device recall Z-1222-2014 · posted 2014-03-19 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.
- Action taken
- Terumo sent an Urgent Medical Device Recall letter dated March 3, 2014, to all affected consignees. The letter included the reason for removal, potential hazards, and customer instructions. Terumo CVS advised users to stop using the affected devices and return any unused product on hand. Questions or concerns were directed to Terumo CVS Customer Service: 1-800-521-2818 M-F, 8am-6pm. For questions regarding this recall call 734-741-6173.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DWF
- Distribution
- Worldwide Distribution - USA including CA, CT, FL, GA, IL, IN, LA, MI, MN, MO, NC, NY, PA, TN, TX, and Internationallly to United Arab Emirates (UAE), Taiwan, Thailand, Malaysia, Belgium, Japan, Mexic
- Date initiated
- 2014-03-03
- Date posted
- 2014-03-19
- Date terminated
- 2014-08-12
- Location
- Ann Arbor, MI
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION OF SARNS TWO STAGE VENOUS CANNULA (K920902) | 3M Health Care, Sarns | 1993-05-11 |