Z-1273-2022Class II

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

Name: Z-1273-2022 REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO
Creator: Bard Peripheral Vascular Inc
Published: 2022-04-22
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2022-04-22 / Open, Classified

FDA source

Bard Peripheral Vascular Inc began a recall of REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO on 2022-04-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1273-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-22
Posted: 2022-06-21
Recalling firm: Bard Peripheral Vascular Inc
Product: REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
Product code: PXI Thoracentesis Tray
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.
FDA root cause: Under Investigation by firm
Action: On March 18, 2022, Bard Peripheral Vascular issued a "Urgent Medical Device Correction" notification to affected consignees via E-Mail or Fed Ex. The notification ask consignees to take the following actions: 1. Please check all inventory locations within your institution for the product listed in Table A and immediately destroy all affected product remaining in your possession. The product should have the sterile barrier broken and destroyed per your local facility s destruction process. 2. Share this notification with all users within your facility network of the product to ensure they are also aware of this field action. 3. If you purchased this product from a distributor, contact your distributor for further instructions and credit resolution. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements and subsequently process your product replacement or credit. 5. Indicate on the response form the quantity of affected product identified at your facility and confirm that this inventory was destroyed. 6. Please contact your BD representative to assist in this process or you may also contact the number for further assistance. 7. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch; Phone: 1-800-FDA-1088 (1-800-332-1088); Mail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville, MD 20852-9787
Quantity in commerce: 1460 units
Distribution: 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.
Product codes and lots: Lot # 0001405396; UDI/DI: (01)10885403076114

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1273-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1273-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-29	2022-06-21

Product code PXI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)