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Class 2 Device Recall SafeTCentesis Kit 6FR x 16CM |
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| Date Initiated by Firm |
April 22, 2022 |
| Create Date |
June 21, 2022 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1273-2022 |
| Recall Event ID |
90201 |
| Product Classification |
Thoracentesis tray - Product Code PXI
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| Product |
REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO, |
| Code Information |
Lot # 0001405396; UDI/DI: (01)10885403076114 |
Recalling Firm/
Manufacturer |
Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
Tempe AZ 85281-2438
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| For Additional Information Contact |
North America Regional Complaint Center
480-303-2602
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Manufacturer 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.
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FDA Determined
Cause 2 |
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. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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