RecallRadar

FDA Device recall Z-1970-2018

Radial Artery Catheterization Kit

On 2018-06-06 the FDA classified a Class II recall of Radial Artery Catheterization Kit by Arrow International, citing product sterility may be compromised due to unsealed packaging.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1970-2018
ClassificationClass II
Statusterminated
Initiated2018-04-11
Published2018-06-06
Last updated2026-09-13 11:54 UTC
CompanyArrow International
DistributionUS

Product

Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1

Reason

Product sterility may be compromised due to unsealed packaging.

Identifiers

code_info
Lot Numbers: Product code ASK-04020-AH: 13F17B0102 13F17C0283 13F17F0221 13F17G0480 13F17J0045 13F17L0127…Lot Numbers: Product code ASK-04020-AH: 13F17B0102 13F17C0283 13F17F0221 13F17G0480 13F17J0045 13F17L0127 Product code ASK-04020-MIHS: 13F17A0174 13F17F0139 Product code ASK-04120-HF1: 13F17C0360 13F17D0034 13F17E0093 13F17F0468 13F17G0269 13F17J0101 13F17K0311 13F17L0489

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1970-2018%22

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