Data Foundry

Medical device recalls 2022

REF: PIG1260K — Class II medical device recall Z-1273-2022

Ongoing recall by Bard Peripheral Vascular Inc, reported 2022-06-29, distributed nationwide. There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. The

Recall numberZ-1273-2022
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmBard Peripheral Vascular Inc, Tempe, AZ, United States
Recall initiated2022-04-22
Classified2022-06-21
Reported by FDA2022-06-29
DistributedNationwide (US)
Quantity1,460 units
UPC / GTIN / UDI-DI10885403076114
Lot numbers0001405396
Model numbers6FR, PIG1260K, X10

Product

REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,

Reason for recall

There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set and drainage bag, vacuum bottle, and wall suction.

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-1273-2022. 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.