CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. REF SU-20802; CalMed Laboratories, Costa Mesa, CA 9262

FDA device recall Z-1177-2008 · posted 2008-06-11 · Terminated

Recall details

Recalling firm

California Medical Laboratories Inc

Reason for recall

Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.

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.

Root cause

Process control

Status

Terminated

Product code

DTS

Quantity affected

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, Belgi

Date initiated

2008-01-24

Date posted

2008-06-11

Date terminated

2013-03-05

Location

Costa Mesa, CA

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