Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
This recall has been terminated (originally issued August 6, 2021).
- Company
- Intuitive Surgical, Inc.
- Recall Initiated
- August 6, 2021
- Terminated
- May 17, 2024
- Recall Number
- Z-0106-2022
- Quantity
- 1625 units
- Firm Location
- Sunnyvale, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
Distribution
US: AZ, AR, CA, CO, DC, FL, GA, IL, IN, IO, MD, MA, MI, MN, MO, NV, NJ, NY, NC, OH, OK, PA, TN, TX, UT, VA, WA OUS: China
Lot / Code Info
Affected Lot Number(s): S90200303, S90200622, S90200727, S90200811, S90200820, S90200831 ,S90200909, S90201008, S90201015 ,S90201103, S90201107, S90201125 ,S90201202, S90201204, S90210114 ,S90210211, S90210225, S90210310 ,S90210318, S90210408, S90210414
Root Cause
Under Investigation by firm
Action Taken
On August 6, 2021, Intuitive Surgical issued an "Urgent Medical Device Recall" notice to affected consignees via Fed Ex. In addition to informing consignees about the recall, Intuitive ask consignees to take the following actions: 1. Inform necessary hospital personnel about this issue. 2. Inform affected personnel when the requested actions have been completed. 3. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 4. Please retain a copy of this letter and the acknowledgement form for your files. 5. All returned affected product will be assessed and credit will be provided for the quantity returned. Intuitive will provide a follow up notification once unaffected product becomes available. 6. If you need further information or support concerning this Medical Device Notification, please contact your Endoluminal Sales Representative or contact Intuitive Customer Service at the numbers listed below: " North America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com.