CLASS II ONGOING Device recall · Reported 23 Mar 2022 · FDA Enforcement Report
Lumbar Puncture Tray Adult recalled by Bard Peripheral Vascular
Bard Peripheral Vascular is recalling Lumbar Puncture Tray Adult, distributed nationwide in the US. The recall was initiated on 20 Jan 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0795-2022
- FDA event ID
- 89553
- Recalling firm
- Bard Peripheral Vascular, Tempe, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Jan 2022
- FDA classified
- 16 Mar 2022
- Reported
- 23 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 20 Jan 2022 | Recall initiated by company | |
| 16 Mar 2022 | Classified by FDA | +55 days |
| 23 Mar 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
LUMBAR PUNCTURE TRAY ADULT 18G X 3.5
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Why was it recalled?
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Which lots are affected?
Catalog Number: 4303C Lot Numbers/UDI (GTIN, DI + PI): 0001411294 (01)10885403057021(17)220331(10)0001411294 0001414259 (01)10885403057021(17)220331(10)0001414259 0001414361 (01)10885403057021(17)220331(10)0001414361 0001415025 (01)10885403057021(17)220430(10)0001415025 0001417547 (01)10885403057021(17)220430(10)0001417547 0001422377 (01)10885403057021(17)220630(10)0001422377 0001425366 (01)10885403057021(17)220630(10)0001425366 0001426588 (01)10885403057021(17)220630(10)0001426588 0001428500 (01)10885403057021(17)220630(10)0001428500 0001431408 (01)10885403057021(17)220630(10)0001431408 0001433267 (01)10885403057021(17)220831(10)0001433267 0001433868 (01)10885403057021(17)220930(10)0001433868
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 89553This product is part of a recall event; the main page for the event is Lumbar Puncture Tray Pediatric recalled by Bard Peripheral Vascular.
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|---|---|---|---|---|---|
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