FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501

FDA device recall Z-1172-2020 · posted 2020-01-24 · Terminated

Recall details

Recalling firm

Arrow International Inc

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

BSO

Quantity affected

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

Date initiated

2020-01-15

Date posted

2020-01-24

Date terminated

2023-03-17

Location

Reading, PA

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