| Class 2 Device Recall Jamshidi Bone Marrow Biopsy/Aspiration Needles | |
Date Initiated by Firm | June 23, 2021 |
Create Date | August 12, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2247-2021 |
Recall Event ID |
88314 |
510(K)Number | K171531 |
Product Classification |
Instrument, biopsy - Product Code KNW
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Product | TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm;
TJC3513 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm;
TJM4011 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 11G x 10cm;
TJC4011 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 11G x 10cm;
TJM4008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 10cm;
TJC4008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 10cm; |
Code Information |
Catalog Number//UDI: TJM6008/(01)10885403044595(17)241031(10)0001330707; TJC3513/(01)1088540344014(17)241031(10)0001330400; TJM4011/(01)10885403044588(17)241031(10)0001330949; TJC4011/(01)10885403044052(17)241031(10)0001331232; TJM4008/(01)10885403044564(10)0001331230(17)241031; TJC4008/(01)10885403044038(17)241130(10)0001334951; Serial Numbers: 0001330707; 0001330400; 0001330400; 0001330400; 0001331232; 0001331230; 0001334951; |
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 | Padraic OBrien 480-597-8203 |
Manufacturer Reason for Recall | Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile. |
FDA Determined Cause 2 | Packaging process control |
Action | On 07/15/2021, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Notification via FedEx to customers/distributors informing them that the firm has confirmed a complaint regarding an open packaging seal, breaking the sterile barrier.
Customers are instructed to:
1. Please check all inventory locations within their institution for the product listed in Table A and immediately destroy all affected product remaining in their possession. The product should have the sterile barrier broken and destroyed per their local facilitys destruction process.
2. Share this notice with any users of the product within their facilities to ensure they are also aware of this Urgent Medical Device Correction.
3. If they purchased this product from a distributor, contact their distributor for further instructions.
4. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the notification, whether or not they have any affected product, so that the Recalling Firm may acknowledge their receipt of this notification and process your replacement.
5. Please contact their Recalling Firm's representative to assist in this process or they may also contact the number below for further assistance.
The Recalling Firm will:
1. Issue replacements for all customers affected by the recall following receipt of the completed Customer Response Form.
2. taken action to prevent recurrence of this product issue.
For questions or assistance contact (Recall Questions/Product Complaints/Technical Questions):
North American Regional Complaint Center
1-844-8BD- LIFE (1-844-823-5433), Say Recall when prompted
M-F 8am - 5pm CT |
Quantity in Commerce | 3,961 devices |
Distribution | U.S Nationwide Distribution in the states of .: AZ, CT, DC, FL, IL, MA, MI, MO, NY, OK, TX, and VA
O.U.S.: Australia, Belgium, China, EMEA, Japan, Mexico, Saudi Arabia, Singapore, Taiwan |
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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510(K) Database | 510(K)s with Product Code = KNW
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