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CalMed Malleable Pericardial Sump, Single Use Only. Do Not… recallZ-1177-2008 · California Medical Laboratories Inc · initiated Jan 24, 2008

Terminated All recalls posted in June 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from California Medical Laboratories Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-1177-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jan 24, 2008
Posted by the FDA
Jun 11, 2008
Recalling firm
California Medical Laboratories Inc
Quantity
31,124 units of all models
Product code
DTS
FDA submissions
K982891
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.

Product description

CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. REF SU-20802; CalMed Laboratories, Costa Mesa, CA 92626

Code information (models, lots, serial numbers)

Catalog Number SU-20802, Lot Numbers: S040870 S041515 S050537 S050907 S050919 S051982 S052118 S052325 S060056 S060158 S060909 S060924 S070307 S071047 S071462NS S071463 S071620 S071754 and S071985.

Other devices under the same FDA submission

4 devices cleared under K982891 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 46745).

Sources and updates

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