Device recall: Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer
Class II FDA enforcement event 89553. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Bard Peripheral Vascular Inc started this device recall on 20 Jan 2022. The firm address in the FDA record is in Tempe, AZ. FDA put the recall in Class II. FDA event 89553 has 11 product records. The first FDA enforcement report date is 23 Mar 2022. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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,…
Recalling firm
Bard Peripheral Vascular Inc, Tempe, AZ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
11 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0790-2022 | Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer | 20,400 devices | Class II | Ongoing | 23 Mar 2022 |
| Z-0791-2022 | LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5 | 11,970 devices | Class II | Ongoing | 23 Mar 2022 |
| Z-0792-2022 | LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP | 116,770 devices | Class II | Ongoing | 23 Mar 2022 |
| Z-0793-2022 | ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G | 1260 devices | Class II | Ongoing | 23 Mar 2022 |
| Z-0794-2022 | SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT | 49,760 devices | Class II | Ongoing | 23 Mar 2022 |
| Z-0795-2022 | LUMBAR PUNCTURE TRAY ADULT 18G X 3.5 | 8,630 devices | Class II | Ongoing | 23 Mar 2022 |
| Z-0796-2022 | LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL | 29,870 devices | Class II | Ongoing | 23 Mar 2022 |
| Z-0797-2022 | SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT | 15,650 devices | Class II | Ongoing | 23 Mar 2022 |
| Z-0798-2022 | ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY | 2,880 devices | Class II | Ongoing | 23 Mar 2022 |
| Z-0799-2022 | LUMBAR PUNCTURE DRUG FREE TRAY 22G | 2,880 devices | Class II | Ongoing | 23 Mar 2022 |
| Z-0800-2022 | SAFE-T PLUS ATRAUMATIC ADULT LP TRAY | 3,240 devices | Class II | Ongoing | 23 Mar 2022 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2022
- 839
- Share of these events in Class II
- 88%
- Product records in this event
- 11Median of the firm: 1
- Events of the firm on the register
- 56
Other events of the firm
Official channels
- FDA enforcement report Z-0790-2022The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 89553. https://recallregister.com/fda/ii/89553/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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,…
- What quantity of product is in FDA event 89553?
- The event has 11 product records. The first record gives this quantity:
20,400 devices
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 88% of the 839 device events that started in 2022 are in Class II.