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Recall Observatory FDA recall evidence

Device product

ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit

Z-0114-2015

September 15, 2014

Class II

Product summary

Firm
Arrow International Inc
Event
Event 69256
Status
Terminated
Classification
Class II
Quantity
300
Official record key
device-enforcement:Z-0114-2015

Official wording

Reason: Arrow International, Inc. is notifying customers that lot 23F13K0969 of product code ASK-05501-AFH1 contains an incorrect component. The lidstock indicates that the kit contains one Syringe, 10mL, Luer-Slip Loss of Resistance, Glass but contains one Syringe, 10mL, Luer-Lock Loss of Resistance, Glass.

Code information: Catalog No. ASK-05501-AFH1 Lot Number 23F13K0969

Distribution pattern: US Distribution in Utah only.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Arrow International, Inc. is notifying customers that lot 23F13K0969 of product code ASK-05501-AFH1 contains an incorrect component. The lidstock indicates that the kit contains one Syringe, 10mL, Luer-Slip Loss of Resistance, Glass but contains one Syringe, 10mL, Luer-Lock Loss of Resistance, Glass.