Z-2129-2020Class II

Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar...

Name: Z-2129-2020 Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar...
Creator: Teleflex Medical Inc
Published: 2019-10-11
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2019-10-11 / Open, Classified / root cause: manufacturing process

FDA source

TELEFLEX MEDICAL INC began a recall of 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... on 2019-10-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2129-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-10-11
Posted: 2020-05-26
Recalling firm: Teleflex Medical
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.
Product code: BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
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.
Root cause tag: manufacturing process
FDA 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 [email protected]. 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 [email protected]. 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 [email protected]. 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 in commerce: 4227 devices
Distribution: Nationwide distribution.
Product codes and lots: Lot/Batch Numbers: 74A1900698, 74C1902955, 74C1900349, 74C1900137, 74E1802338, 74G1802129, 74H1802488, 74K1800901, 74K1801734, 74L1802219

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2129-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2129-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-03	2020-05-26
Z-2130-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-03	2020-05-26

Product code BSP

K911260Class IIAtraumatic Standard Sprotte NeedlePajunk GmbH / cleared 1991-10-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)