| | Class 2 Device Recall Adult Lumbar Puncture Tray |  |
| Date Initiated by Firm | January 20, 2022 |
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| Create Date | March 16, 2022 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0792-2022 |
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| Recall Event ID |
89553 |
| Product Classification |
Lumbar puncture tray (adult & pediatric) - Product Code PWY
|
| Product | LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP |
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| Code Information |
Catalog Number: 4301C
Lot Numbers/UDI (GTIN, DI + PI):
0001410711 (01)10885403057038(17)220331(10)0001410711
0001411299 (01)10885403057038(17)220331(10)0001411299
0001411867 (01)10885403057038(17)220331(10)0001411867
0001414258 (01)10885403057038(17)220331(10)0001414258
0001414358 (01)10885403057038(17)220331(10)0001414358
0001414359 (01)10885403057038(17)220331(10)0001414359
0001415031 (01)10885403057038(17)220430(10)0001415031
0001415038 (01)10885403057038(17)220430(10)0001415038
0001415850 (01)10885403057038(17)220430(10)0001415850
0001415809 (01)10885403057038(17)220430(10)0001415809
0001417243 (01)10885403057038(17)220430(10)0001417243
0001417244 (01)10885403057038(17)220430(10)0001417244
0001417734 (01)10885403057038(17)220430(10)0001417734
0001418034 (01)10885403057038(17)220430(10)0001418034
0001418308 (01)10885403057038(17)220430(10)0001418308
0001418410 (01)10885403057038(17)220430(10)0001418410
0001421652 (01)10885403057038(17)220630(10)0001421652
0001421921 (01)10885403057038(17)220630(10)0001421921
0001422197 (01)10885403057038(17)220630(10)0001422197
0001422150 (01)10885403057038(17)220630(10)0001422150
0001422604 (01)10885403057038(17)220630(10)0001422604
0001425527 (01)10885403057038(17)220630(10)0001425527
0001425874 (01)10885403057038(17)220630(10)0001425874
0001426189 (01)10885403057038(17)220630(10)0001426189
0001426502 (01)10885403057038(17)220630(10)0001426502
0001427225 (01)10885403057038(17)220630(10)0001427225
0001427380 (01)10885403057038(17)220630(10)0001427380
0001429130 (01)10885403057038(17)220630(10)0001429130
0001429519 (01)10885403057038(17)220630(10)0001429519
0001430121 (01)10885403057038(17)220630(10)0001430121
0001430608 (01)10885403057038(17)220630(10)0001430608
0001431407 (01)10885403057038(17)220630(10)0001431407
0001431472 (01)10885403057038(17)220630(10)0001431472
0001432176 (01)10885403057038(17)220630(10)0001432176
0001432655 (01)10885403057038(17)220831(10)0001432655
0001433601 (01)10885403057038(17)220930(10)0001433601
0001433023 (01)10885403057038(17)220930(10)0001433023
0001434251 (01)10885403057038(17)220930(10)0001434251
0001434730 (01)10885403057038(17)220930(10)0001434730
0001436141 (01)10885403057038(17)220930(10)0001436141
0001437469 (01)10885403057038(17)221031(10)0001437469
0001437660 (01)10885403057038(17)221031(10)0001437660
0001437658 (01)10885403057038(17)221031(10)0001437658
0001437768 (01)10885403057038(17)221031(10)0001437768
|
| FEI Number |
2020394
|
Recalling Firm/
Manufacturer |
Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
Tempe AZ 85281-2438
|
| For Additional Information Contact | North American Regional Complaint Center
844-823-5433 |
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Manufacturer Reason
for Recall | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. |
|---|
FDA Determined
Cause 2 | Process control |
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| Action | Between 01/28 and 02/01/2022, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Letter via email and FedEx 2-day mailings to customers informing them that between 07/02 to 12/15/2021 the firm received 59 customer complaints for lumbar puncture tray manometers with reported failure modes of leaking and mating issues.
Customers are asked to take the following actions:
1. 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 facility s destruction process.
2. Share this notification with all users within their facilities to ensure they are also aware of this Urgent Medical Device Correction.
3. If Customers purchased this product from a distributor, contact their distributor for further instructions and credit resolution.
4. Complete and return the attached Customer Response Form to the Recalling Firm contact noted on the form confirming acknowledgement of the correction notification, whether or not they have any affected product, so that the Recalling Firm may acknowledge their receipt of this notification and process their credit.
5. Indicate on the response form the quantity of affected product identified at their facility and confirm that this inventory was destroyed.
6. Contact their Recalling Firm's representative to assist in this process or they may also contact the listed in the notification for further assistance.
For further assistance contact:
North American Regional Complaint Center -
1-844-8BD- LIFE (1-844-823-5433), Say Recall when prompted
M-F 8am - 5pm CT |
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| Quantity in Commerce | 116,770 devices |
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| Distribution | U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
O.U.S. (foreign) including states: Costa Rica and Hong Kong. |
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| 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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