Z-2130-2020 Class II Ongoing
FDA device recall Z-2130-2020 was initiated by TELEFLEX MEDICAL INC on October 11, 2019 and is designated Class II. Reason for recall: Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging… The recall status is ongoing. Affected quantity: 800 devices.
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2020
- Initiation Date
- October 11, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 800 devices
Product Description
Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/discography procedures.
Reason for Recall
Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas with introducer. Due to this problem Pajunk cannot guarantee the sterility of the affected batches.
Distribution Pattern
Nationwide distribution.
Code Information
Lot/Batch Numbers: 74A1900703, 74D1802540, 74E1800978, 74F1801413, 74G1800896, 74H1800162, 74K1801738, 74K1802909, 74L1800502