This is to inform the public and concerned healthcare professionals that the Voluntary Recall order issued on specific lots of Jamshidi™ Bone Marrow Biopsy / Aspiration Needle, with Luer-Lock Adapter 11GX4 ASP as shown in the table below is hereby terminated by the Food and Drug Administration (FDA).
|
Product Name |
Product Code | Lot Number |
| Jamshidi™ Bone Marrow Biopsy / Aspiration Needle, with Luer-Lock Adapter 11GX4 ASP |
DJ4011X |
0001303256 |
|
0001303257 |
As stated in the FDA Advisory No. 2020-1382 dated 20 July 2020, Lifelink Inc. has conducted the voluntary recall of the aforementioned product in response to the information provided by their supplier, Becton, Dickinson and Company (BD). According to their supplier, the affected medical device product listed in the table above maybe at risk of having some packaging pouches that was not sealed properly. When used, the improperly sealed medical device product may introduce contaminants or disease vectors into the patient’s body which may lead to contamination or infection.
After due and thorough evaluation of the submitted documents by Lifelink Inc., FDA has determined that reasonable efforts have been made to recall and properly destroy the affected product lots in accordance with FDA Circular No. 2016-012, known as the Guidelines on Product Recall.
The issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be subsequent findings of any violation of existing FDA laws, rules and regulations.
All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to monitor and seize the cited product lots if still found available in the market.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 8857-1900 local 8301.
Dissemination of this advisory to all concerned is hereby requested.
Attachment:-> FDA-Advisory-No.2020-1382-A