ClearanceBrief
Recall Z-0765-2023 ยท KDC Instrument, Surgical, Disposable

Medical Action Industries, Inc. 306

Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, REF 56247, packaged 1/package, 20 packages/box, 12 boxes/case, sterile.

DateDec 22, 2022 (initiated Oct 12, 2022)
StatusTerminated
ReasonScissors contained debris.
Root causeUnder Investigation by firm
ActionThe recalling firm issued letters dated 10/12/2022 via email on 10/12/2022. The letter identified the affected product, the reason for recall, and requested the consignee review their inventory and segregate and quarantine all affected product. If any of the product is found, the consignee is to discard it. If the product was further distributed, the consignee is to ensure all end users are appropriately notified of the field correction. A Field Action response Form was to be completed and returned via email as soon as possible to indicate they have read and understand the recall instructio
Quantity145 cases (240 scissors/case)
DistributionDistribution was made to FL, IL, IN, MA, MD, MO, OH, and VA. There was no foreign/government/military distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.