Recall Z-1175-2008 ยท DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass
California Medical Laboratories Inc
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
| Date | Jun 11, 2008 (initiated Jan 24, 2008) |
| Status | Terminated |
| Reason | Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product. |
| Root cause | Process control |
| Action | 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 loo |
| 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, Me |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982891 | CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS California Medical Laboratories, Inc., Sep 30, 1998 |