TELEFLEX MEDICAL INC: Sprotte Needle, REF 32115130C w/ Intro 22 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.

Recall number

Z-2129-2020

Recalling firm

TELEFLEX MEDICAL INC

Product

Sprotte Needle, REF 32115130C w/ Intro 22 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.

Status

Open, Classified

Initiated

2019-10-11

Posted

not on file

Terminated

not on file

Reason

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.

Root cause

Process control

Action

The firm, Teleflex Medical, initiated the recall by letter on 10/11/2019. The notice requested that the consignees take actions as follows: Distributors: 1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed in the letter. 2. Using the provided customer letter and recall acknowledgement form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. In the event that an alternative approach is needed, contact Teleflex Customer Service for more information at 1-866-396-2111. 4. To return recalled products to Teleflex Medical, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex Medical. 5. Once you have completed returning all of the recalled products from your own inventory, and collecting and consolidating all of the recalled products from your customers, please check the box on the enclosed Recall Acknowledgment Form that indicates that you have completed the recall and fax it to 1-855-419-8507, Attn: Customer Service, or email it to recalls@teleflex.com. This will allow us to document completion of the recall. 6. If you and your customers have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter. Customer of Teleflex Products: 1. If you have affected stock in inventory, immed

Quantity

4227 devices

Distribution

Nationwide distribution.

Lot, serial or model codes

Lot/Batch Numbers: 74A1900698, 74C1902955, 74C1900349, 74C1900137, 74E1802338, 74G1802129, 74H1802488, 74K1800901, 74K1801734, 74L1802219

510(k) numbers

["K911260"]

PMA numbers

not on file

Product code

BSP

Firm FEI

3005747797

Firm city

Morrisville

Firm state

NC

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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