Safe-T recallZ-0794-2022 · Bard Peripheral Vascular Inc · initiated Jan 20, 2022

Why it was recalled

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

FDA root cause category: Process control

What the company is doing

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

Recall details

Recall number

Z-0794-2022

Status

Open, Classified

Initiated by the company

Jan 20, 2022

Recalling firm

Bard Peripheral Vascular Inc

Quantity

49,760 devices

Product code

PWY

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 description

SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Safe-T 4301CSP

  Carefusion 2200, Inc · Lumbar puncture tray (adult & pediatric)
  1 recall7 reports

Product lines

• Safe-TCarefusion 2200, Inc · 9 models · 26 reports · 8 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 89553).

• Z-0790-2022 · Open, Classified
  Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer
• Z-0791-2022 · Open, Classified
  LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
• Z-0792-2022 · Open, Classified
  LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP
• Z-0793-2022 · Open, Classified
  ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G
• Z-0795-2022 · Open, Classified
  LUMBAR PUNCTURE TRAY ADULT 18G X 3.5
• Z-0796-2022 · Open, Classified
  LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL
• Z-0797-2022 · Open, Classified
  SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT
• Z-0798-2022 · Open, Classified
  ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY
• Z-0799-2022 · Open, Classified
  LUMBAR PUNCTURE DRUG FREE TRAY 22G
• Z-0800-2022 · Open, Classified
  SAFE-T PLUS ATRAUMATIC ADULT LP TRAY