CLASS II ONGOING Device recall · Reported 23 Mar 2022 · FDA Enforcement Report
Atraumatic Adult Lumbar Puncture Tray recalled
Bard Peripheral Vascular is recalling Atraumatic Adult Lumbar Puncture Tray, 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-0798-2022
- 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
ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY
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: 4306CW Lot Numbers/UDI (GTIN, DI + PI): 0001415028 (01)10885403228995(17)220430(10)0001415028 0001417842 (01)10885403228995(17)220430(10)0001417842 0001424355 (01)10885403228995(17)220630(10)0001424355 0001431413 (01)10885403228995(17)220630(10)0001431413 0001436376 (01)10885403228995(17)220930(10)0001436376
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.
More recalls from Bard Peripheral Vascular
All 138| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Broviac 4. Single-Lumen CV Catheter Cutdown Tray recalled | Bard Peripheral Vascular | Sterility | Nationwide |
| Device | CLASS II | Safe-T-Centesis Catheter Drainage Tray recalled | Bard Peripheral Vascular | Other | Nationwide |
| Device | CLASS II | Venclose digiRF Generators recalled by Bard Peripheral Vascular | Bard Peripheral Vascular | Temperature Abuse | Nationwide |
| Device | CLASS I | Rotarex Atherectomy System and Instructions for Use recalled | Bard Peripheral Vascular | Device Malfunction | Nationwide |
| Device | CLASS II | Bard Marquee Disposable Core Biopsy Instrument Kit: Bard Marquee Kit recalled | Bard Peripheral Vascular | Other | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |