—#193733

Product

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

FDA product code: PXI — Thoracentesis Tray
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Lot # 0001405396; UDI/DI: (01)10885403076114

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Bldg 1, Tempe, Arizona 85281-2438

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2022-04-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #193733. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.