Data Foundry

Medical device recalls 2021

5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm… — Class II medical device recall Z-1994-2021

Terminated recall by Bard Access Systems Inc., reported 2021-07-07, distributed nationwide. Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contain

Recall numberZ-1994-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBard Access Systems Inc., Salt Lake City, UT, United States
Recall initiated2021-05-19
Classified2021-07-01
Reported by FDA2021-07-07
Terminated2023-03-31
DistributedNationwide (US)
Quantity30 kits
Reason classeslabeling
UPC / GTIN / UDI-DI00801741126697
Lot numbers20BBK658
Model numbers20BBK658, CK000340B

Product

5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire

Reason for recall

Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1994-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.