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

Recall number

Z-1273-2022

Recalling firm

Bard Peripheral Vascular Inc

Product

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

Status

Open, Classified

Initiated

2022-04-22

Posted

not on file

Terminated

not on file

Reason

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.

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

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.

Lot, serial or model codes

Lot # 0001405396; UDI/DI: (01)10885403076114

510(k) numbers

not on file

PMA numbers

not on file

Product code

PXI

Firm FEI

2020394

Firm city

Tempe

Firm state

AZ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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