ClearanceBrief
Recall Z-1299-2018 ยท KDD Kit, Surgical Instrument, Disposable

Arrow International Inc

Pneumothorax Kit

DateOct 24, 2017
StatusTerminated
ReasonProduct packaging may not be completely sealed.
Root causeComponent design/selection
ActionOn October 24, 2017 and Urgent Medical Device Recall letter was issued to customers to review inventory and if there's any affected stock, to immediately discontinue use, quarantine and prepare to return to recalling firm. Questions or concerns can be directed to 1-855-419-8507 or 1-866-246-6990
DistributionNationally
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K904021PNEUMOTHORAX KIT, MODIFICATION
Arrow Intl., Inc., Oct 9, 1990