Recall Z-1175-2008
California Medical Laboratories Inc · initiated January 24, 2008
Product
CalMed Pericardial Sump, with 1/8"/0.3175 cm Connector Single Use Only. Do Not Reuse. REF SU-20601; CalMed Laboratories, Costa Mesa, CA 92626
Codes / lots: Catalog Number SU-20601, Lot Number S03482
Reason for recall
Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.
FDA-determined cause: Process control
Action taken
CalMed emailed letters to consignees on 1/24/2008 notifying customers of the recall. The letter advises that that the following Medical Devices are subject to an immediate Voluntary Recall for Correction: Pericardial Sump (Catalog #SU-20601), Pericardial Sump (Catalog #SU-20602), and Malleable Pericardial Sump (Catalog #SU-20802). It is asked that further distribution or use of any remaining product should cease immediately. Where appropriate, the firm asks that consignees notify their own customers who received the product of the same. The Product is being recalled due to a potentially loose, stainless steel stringer flash located at the distal tip of the Product. Customers are asked to contact the firm's Quality Assurance Manager immediately for purposes of issuing a Returned Goods Authorization and coordinating the return of the Subject Medical Devices such that they may be inspected and nonconforming product removed. A response is requested via e-mail.
Details
- Recall number
- Z-1175-2008
- Initiated
- January 24, 2008
- Posted by FDA
- June 11, 2008
- Terminated
- March 5, 2013
- Product code
- DTS – Sucker, Cardiotomy Return, Cardiopulmonary Bypass
- Quantity
- 31,124 units of all models
- Distribution
- Worldwide Distribution - USA, Turkey, Brazil, Germany, Italy, Spain, Philippines, South Africa, Japan, Israel, Saudi Arabia, United Arab Emirates, India, Ireland, China, Hungary, Poland, Taiwan, Belgium, Pakistan, Lithuania, Greece, Canada, Syria, Israel, Austria, Denmark, Bangladesh, Costa Rica, Mexico, Spain, and Sultanate of Oman.
- Recalling firm
- California Medical Laboratories Inc, Costa Mesa, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1176-2008 | CalMed Pericardial Sump, with 1/4"/0.635 cm Connector, Single Use Only. Do Not Reuse…Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip… | 01/24/2008Terminated |
| Z-1177-2008 | CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. REF SU-20802; CalMed…Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip… | 01/24/2008Terminated |