Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Needle Single Shot Epidural Kit permits access to the epidural space.
- Company
- Arrow International Inc
- Recall Initiated
- July 6, 2020
- Terminated
- November 5, 2021
- Recall Number
- Z-2801-2020
- Firm Location
- Reading, PA
Reason for Recall
The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.
Distribution
World wide distribution
Lot / Code Info
Product Code: AK-03000-S Lot #: 13F17J0230
Root Cause
Incorrect or no expiration date
Action Taken
Arrow sent a customer notification letter dated July 6, 2020. This letter informed customers of the affected product, asked them to check and remove inventory, and complete the response form.
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