Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns&amp
FDA device recall Z-0670-2013 · posted 2013-01-11 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
- Action taken
- TERUMO sent an URGENT MEDICAL DEVICE RECALL notification to all consignees on January 7, 2013. Terumo CVS is advising users to discontinue use and return all affected cannulae in inventory. Terumo CVS will issue credit for returned cannulae. Terumo CVS providied a list of marketed devices that can be used as alternatives. Contact Terumo CVS Customer Service with questions or concerns: 800- 521- 2818 Monday Friday, 8 AM - 6 PM EST For questions regarding this recall call 734-741-6173.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 6830 total all products
- Distribution
- Nationwide and worldwide: AL , AR , AZ , CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , ME , MI, MO , NC , ND , NV , NY , OH , OK , PA , SD , TN , TX , UT , VA , WA , and WI. Bahrain
- Date initiated
- 2013-01-07
- Date posted
- 2013-01-11
- Date terminated
- 2013-08-26
- Location
- Ann Arbor, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS (K083301) | Terumo Cardiovascular Systems Corp. | 2008-12-18 |
| FLEXIBLE ARTERIAL CANNULAE (K771499) | 3M Health Care, Sarns | 1977-08-16 |
| CANNULAE, AORTIC, ARCH, HIGH FLOW (K770429) | 3M Health Care, Sarns | 1977-03-16 |