California Medical Laboratories Recalls Sterile Rigid Tip Suction Wands
California Medical Laboratories is recalling sterile rigid tip suction wands because the distal tip may detach and fall into a patient's chest cavity during surgery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device used during surgery where a component may detach and enter the patient's body, posing a significant risk of injury, which aligns with the 'Severe' criteria for structural defects or significant injury reports.
Plain-English summary
California Medical Laboratories, Inc. is recalling sterile rigid tip suction wands, catalog number SU-12202. The affected units are identified by lot numbers S112462 and S111480. The product is indicated for use to remove excess fluid from the surgical field.
The recall is due to insufficient adhesive application, which creates a potential for the distal tip to come loose from the wand and fall into the patient's chest cavity. The agency has classified this as a Class II recall.
The affected products were distributed worldwide, including in the United States (Arizona, Florida, California, Louisiana, Colorado, and Mississippi) and internationally to Canada, Israel, Greece, Hong Kong, India, Ireland, Jordan, Lebanon, Malaysia, the Netherlands, Russia, Saudi Arabia, South Africa, and Spain. Healthcare providers should stop using the affected units and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.
- Manufacturer
- California Medical Laboratories Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog No: SU-12202 Lot No: S112462
- S111480
Distribution
Part of a larger recall action
This product is one of 2 recalled by California Medical Laboratories Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · California Medical Laboratories Inc
See all →- SevereCalifornia Medical Laboratories Recalls Rigid Tip Suction Wands Due to Tip Detachment Risk
FDA (Devices) · 2013-01-16
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