CLASS II ONGOING Device recall · Reported 29 Jun 2022 · FDA Enforcement Report
REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit recalled
Bard Peripheral Vascular is recalling REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, distributed nationwide in the US. The recall was initiated on 22 Apr 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1273-2022
- FDA event ID
- 90201
- Recalling firm
- Bard Peripheral Vascular, Tempe, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Apr 2022
- FDA classified
- 21 Jun 2022
- Reported
- 29 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 22 Apr 2022 | Recall initiated by company | |
| 21 Jun 2022 | Classified by FDA | +60 days |
| 29 Jun 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of MS, NC, FL, KS, GA, OH, AZ, NV, OH, IL, MI, MO,IA, CA, PA, AL,WA, TN, IN, NY and the countries of AU, BE, NZ.
Nationwide AlabamaArizonaCaliforniaFloridaGeorgiaIowaIllinoisIndianaKansasMichiganMissouriMississippiNorth CarolinaNevadaNew YorkOhioPennsylvaniaTennesseeWashington
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot # 0001405396; UDI/DI: (01)10885403076114
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of MS, NC, FL, KS, GA, OH, AZ, NV, OH, IL, MI, MO,IA, CA, PA, AL,WA, TN, IN, NY and the countries of AU, BE, NZ.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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