Sterile Rigid Tip Suction Wand recallZ-0649-2013 · California Medical Laboratories Inc · initiated Nov 2, 2012
Class II Terminated All recalls posted in January 2013
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
California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.
FDA root cause category: Nonconforming Material/Component
What the company is doing
CalMed sent an Urgent Field Safety Notice dated November 2, 2012, to all affected customers by certified mail and additionally followed up via electronic mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact Sorin Group USA's Customers Service Department at +1-800-650-2623 to return any unused product and order replacements. Customers were also asked to communicate the important safety information to all potential users within their organization or any other organization where the affected product may have been transferred and to maintain awareness of this communication for an appropriate period of time to ensure effectiveness of the corrective action. Customers were asked to return all unused product to CalMed Labs. Customers with questions were instructed to contact California Medical Laboratories at +1-714-556-7365. For questions regarding this recall call 714-556-7365.
Recall details
- Recall number
- Z-0649-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 2, 2012
- Posted by the FDA
- Jan 7, 2013
- Recalling firm
- California Medical Laboratories Inc
- Quantity
- S112462=995 units & S111480 1430 units
- Product code
- DTS
- FDA submissions
- K982891
- Distribution
- Worldwide Distribution - USA including AZ, FL, CA, LA, CO, and MS. Internationally to Canada, Israel, Greece, Hong Kong, India, Ireland, Jordan, Lebanon, Malaysia, Netherlands, Russia, Saudi Arabia, South Africa and Spain.
Product description
Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.
Code information (models, lots, serial numbers)
Catalog No: SU-12202 Lot No: S112462, S111480
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-xxxxxLivanova USA, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS9 reports
- Suction tip SU-xxxxxLivanova USA, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS6 reports
- Suction tip SU-xxxxxLivanova USA, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS2 reports
- Suction tip SU-xxxxxLivanova USA, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 63896).
- Z-0650-2013 · TerminatedRigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction …
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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