CalMed Pericardial Sump, with 1/4"/0.635 cm Connector… recallZ-1176-2008 · California Medical Laboratories Inc · initiated Jan 24, 2008

Terminated All recalls posted in June 2008

Is my device affected?

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.
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.
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-1176-2008
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 Pericardial Sump, with 1/4"/0.635 cm Connector, Single Use Only. Do Not Reuse; REF SU-20602; CalMed Laboratories, Costa Mesa, CA 92626

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Catalog Number SU-20602, Lot Numbers: S040846 S040754 S040914 S041006 S041122 S050061NS S050232 S050233 S050329 S050335NS S050416NS S050538NS S050741 S050759NS S050766NS S050858 S050923NS S050943NS S051041 S051130 S051151 S051175 S051275NS S051318NS S051356NS S051402NS S051490 S051511 S051560NS S051582NS S051596NS S051677ES S051844NS S051881 S051906ES S051925 S052007NS S052142NS S052193NS S052295 S052338NS S060045 S060092NS S060202 S060285 S060401NS S060402NS S060454NS Lot No. S060492NS S060683NS S060965NS S061010NS S061226 S061434 S061441NS S061513NS S061695NS S061760NS S061838NS S061916 S062015NS S062055NS S062132 S070135NS S070252NS S070324 S070482NS S070501NS S070633 S070820NS S070870NS S070882 S070998 S071002NS S071456NS S071457NS S071458 S071459NS S071460NS S071534 S071606 S071607 S071688 S071731NS S071766 S071989 S072100NS S072121NS, and S072133NS

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.

Suction tip SU-xxxxx
Livanova USA, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
9 reports
Suction tip SU-xxxxx
Livanova USA, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
6 reports
Suction tip SU-xxxxx
Livanova USA, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
2 reports
Suction tip SU-xxxxx
Livanova USA, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
2 reports

Other products in the same recall event

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

Z-1175-2008 · Terminated
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
Z-1177-2008 · Terminated
CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. REF SU-20802; CalMed Laboratories, Costa Mesa, CA 92626

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.

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