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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm January 15, 2020
Date Posted January 24, 2020
Recall Status1 Open3, Classified
Recall Number Z-1172-2020
Recall Event ID 84726
510(K)Number K140110  
Product Classification Catheter, Conduction, Anesthetic - Product Code BSO
Product FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501
Code Information Lots: 23F19A0301 23F19F0108 23F19F0481 23F19H0079 23F19J0305 23F19L0094 23F19C0303 23F19F0297 23F19G0039 23F19H0145 23F19J0484 23F19L0209 23F19D0266 23F19F0388 23F19G0263 23F19H0386 23F19K0171 23F19M0112
Recalling Firm/
Manufacturer
Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Customer Service
866-396-2111
Manufacturer Reason
for Recall
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
FDA Determined
Cause 2
Other
Action An Urgent Medical Device Recall notification letter dated 1/15/20 was sent to customers. Our records indicate you have received products that are subject to this field action. We are now notifying our customers to take the following actions: 1. If you have affected stock, immediately identify product, discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To acknowledge receipt of this Urgent Medical Device Recall Notice or to return product, 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 products to Teleflex Medical. 3. If you 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.
Quantity in Commerce 343,105 total
Distribution The products were distributed to the following US states: AK, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY.
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 = BSO and Original Applicant = TELEFLEX, INC.
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