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Recall Observatory FDA recall evidence

Device product

Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Needle Single Shot Epidural Kit permits access to the epidural space.

Z-2801-2020

July 06, 2020

Class II

Product summary

Firm
Arrow International Inc
Event
Event 86044
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2801-2020

Official wording

Reason: 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.

Code information: Product Code: AK-03000-S Lot #: 13F17J0230

Distribution pattern: World wide distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.