Safe-T-Centesis recallZ-1273-2022 · Bard Peripheral Vascular Inc · initiated Apr 22, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bard Peripheral Vascular Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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
Recall details
- Recall number
- Z-1273-2022
- Status
- Open, Classified
- Initiated by the company
- Apr 22, 2022
- Recalling firm
- Bard Peripheral Vascular Inc
- Quantity
- 1460 units
- Product code
- PXI
- 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 description
REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
Code information (models, lots, serial numbers)
Lot # 0001405396; UDI/DI: (01)10885403076114
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Safe-T-Centesis PIG1260KCarefusion 2200, Inc · Thoracentesis tray1 recall73 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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