Laparoscopy Packs Recalled Due to Unconfirmed Sterilization Assurance
American Contract Systems Inc is recalling 630 laparoscopy pack kits due to unconfirmed sterilization assurance. This could cause loss of functionality and treatment delays.
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: This is a Class II recall with no reported hospitalizations or injuries. It qualifies as a risk-of-harm medical device where injury has not yet been reported, justifying a High classification per the rubric.
Plain-English summary
American Contract Systems Inc is recalling LAPAROSCOPY PACK Model Nos LLLA21J and LLLA21J-02. The recall involves 630 kits distributed nationwide in Ohio, identified by UDI-DI 00191072219206 and specific lot numbers (882241, 70-051163, 70-051373, 70-051564, 70-052582, 70-053048).
The company is unable to confirm that sterilization assurance requirements were met during manufacturing. Without proper sterilization, these packs may not function as intended and could lead to delayed or prolonged treatment for patients.
The FDA has classified this as a Class II recall. Healthcare facilities and practitioners who received these kits should contact American Contract Systems Inc for guidance regarding next steps.
The recalled product
- Product
- LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02
- Manufacturer
- American Contract Systems Inc
- Hazard
- sterilization-failure
- loss-of-functionality
Distribution
Distributed nationwide across the United States.
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