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U.S. Department of Health and Human Services

Class 2 Device Recall Sprotte Needle

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  Class 2 Device Recall Sprotte Needle see related information
Date Initiated by Firm October 11, 2019
Create Date May 26, 2020
Recall Status1 Open3, Classified
Recall Number Z-2130-2020
Recall Event ID 85551
510(K)Number K911260  
Product Classification Needle, conduction, anesthetic (w/wo introducer) - Product Code BSP
Product 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.
Code Information Lot/Batch Numbers: 74A1900703, 74D1802540, 74E1800978, 74F1801413, 74G1800896, 74H1800162, 74K1801738, 74K1802909, 74L1800502 
Recalling Firm/
Manufacturer		 TELEFLEX MEDICAL INC
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
For Additional Information Contact Teleflex Customer Service
866-396-2111
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 800 devices
Distribution Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = BSP and Original Applicant = PAJUNK GMBH
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