Z-0791-2022Class II

Lumbar Puncture Tray Pediatric 21G 2.5

Name: Z-0791-2022 Lumbar Puncture Tray Pediatric 21G 2.5
Creator: Bard Peripheral Vascular Inc
Published: 2022-01-20
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2022-01-20 / Open, Classified / root cause: manufacturing process

FDA source

Bard Peripheral Vascular Inc began a recall of LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5 on 2022-01-20. FDA classified it as Class II and gives the reason as "Due to lumbar puncture tray manometer failure mode of leaking and mating issues". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0791-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-20
Posted: 2022-03-16
Recalling firm: Bard Peripheral Vascular Inc
Product: Lumbar Puncture Tray Pediatric 21G 2.5
Product code: PWY Lumbar Puncture Tray (Adult & Pediatric)
Reason for recall: Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Root cause tag: manufacturing process
FDA root cause: Process control
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
Quantity in commerce: 11,970 devices
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.
Product codes and lots: Catalog Number: 4304C Lot Numbers/UDI (GTIN, DI + PI): 0001414261 (01)10885403057052(17)220331(10)0001414261 0001414362 (01)10885403057052(17)220430(10)0001414362 0001415851 (01)10885403057052(17)220430(10)0001415851 0001415026 (01)10885403057052(17)220430(10)0001415026 0001421686 (01)10885403057052(17)220630(10)0001421686 0001424759 (01)10885403057052(17)220630(10)0001424759 0001426324 (01)10885403057052(17)220630(10)0001426324 0001428876 (01)10885403057052(17)220630(10)0001428876 0001432173 (01)10885403057052(17)220630(10)0001432173 0001434168 (01)10885403057052(17)220930(10)0001434168 0001438149 (01)10885403057052(17)221031(10)0001438149 0001438930 (01)10885403057052(17)221031(10)0001438930 0001441010 (01)10885403057052(17)221031(10)0001441010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0791-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0790-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-16
Z-0791-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-16
Z-0792-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-16
Z-0793-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-16
Z-0794-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-16
Z-0795-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-16
Z-0796-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-16
Z-0797-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-16
Z-0798-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-16
Z-0799-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-16
Z-0800-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-16

Product code PWY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)