Aesculap Caiman Disposable Surgical Instrument Recalled for Sterility Concerns
Aesculap Implant Systems LLC is recalling Caiman disposable articulated instruments due to a possibility that the sterility batch was insufficiently sterilized.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for serious injury (such as infection from insufficient sterilization) are categorized as Severe.
Plain-English summary
Aesculap Implant Systems LLC is recalling Caiman disposable articulated instruments (Reference: PL731SU) intended for use in general surgery and gynecologic procedures. The recall is being conducted because of a possibility that the sterility batch was insufficiently sterilized.
The affected product is distributed in the state of California. The specific lot number identified in the recall is 823B. The agency has classified this recall as Class II.
Healthcare providers and facilities should stop using the affected instruments and contact the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- 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 # 823B
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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