| | Class 2 Device Recall SafeT PLUS Pediatric/Infant 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-0790-2022 |
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| Recall Event ID |
89553 |
| Product Classification |
Lumbar puncture tray (adult & pediatric) - Product Code PWY
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| Product | Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer |
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| Code Information |
Catalog Number: 4302CSP
Lot Numbers/UDI (GTIN, DI + PI):
0001412493 (01)10885403107788(17)220331(10)0001412493
0001415324 (01)10885403107788(17)220430(10)0001415324
0001416351 (01)10885403107788(17)220430(10)0001416351
0001417052 (01)10885403107788(17)220430(10)0001417052
0001417550 (01)10885403107788(17)220430(10)0001417550
0001421010 (01)10885403107788(17)220531(10)0001421010
0001422378 (01)10885403107788(17)220630(10)0001422378
0001425085 (01)10885403107788(17)220630(10)0001425085
0001426188 (01)10885403107788(17)220630(10)0001426188
0001426941 (01)10885403107788(17)220630(10)0001426941
0001428873 (01)10885403107788(17)220630(10)0001428873
0001431044 (01)10885403107788(17)220630(10)0001431044
0001433024 (01)10885403107788(17)220831(10)0001433024
0001433846 (01)10885403107788(17)220930(10)0001433846
0001437468 (01)10885403107788(17)221031(10)0001437468
0001438331 (01)10885403107788(17)221031(10)0001438331
0001439310 (01)10885403107788(17)221031(10)0001439310
0001440531 (01)10885403107788(17)221031(10)0001440531
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| FEI Number |
2020394
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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 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. |
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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 | 20,400 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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