Aesculap Caiman Disposable Surgical Instruments Recalled for Sterility Concerns
Aesculap Implant Systems LLC is recalling Caiman disposable articulated instruments due to a possibility of insufficient sterilization.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential sterility failure, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Aesculap Implant Systems LLC is recalling Caiman disposable articulated instruments (Reference PL730SU) intended for use in general surgery and gynecologic procedures. The recall involves 3 units from Lot 837B and Lot 109C. The distribution was nationwide in the United States, specifically within the state of California.
The recall was initiated because of a possibility that the sterility batch was insufficiently sterilized. This defect could potentially compromise the safety of the medical instruments during surgical procedures.
Healthcare facilities and consumers who have these specific instruments should stop using them immediately. They should contact Aesculap Implant Systems LLC for further instructions on how to return or dispose of the affected products.
The recalled product
- Product
- CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
- Manufacturer
- Aesculap Implant Systems LLC
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 (1)
- Lot # 109C and 837B
Distribution
Part of a larger recall action
This product is one of 2 recalled by Aesculap Implant Systems LLC 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.
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