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U.S. Department of Health and Human Services

Class 2 Device Recall Peripherally Inserted Central Catheters (PICC)

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 Class 2 Device Recall Peripherally Inserted Central Catheters (PICC)see related information
Date Initiated by FirmAugust 29, 2016
Create DateDecember 05, 2016
Recall Status1 Terminated 3 on June 15, 2018
Recall NumberZ-0708-2017
Recall Event ID 75322
510(K)NumberK142616 
Product Classification Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
ProductXcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media
Code Information Batch/Lot: 505722, 5056512
Recalling Firm/
Manufacturer
Angiodynamics Inc. (Navilyst Medical Inc.)
10 Glens Falls Tech Park
Glens Falls NY 12801-3864
For Additional Information ContactGary Barrett
518-792-4112
Manufacturer Reason
for Recall
Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves supplied to Navilyst contain an incorrect expiration date. Navilyst has confirmed that Medlines affected sterile gloves (Medline Part Number MSG1075/MSG3075) have been included in a limited number of kits.
FDA Determined
Cause 2
Under Investigation by firm
ActionNavilyst sent an Urgent Voluntary Medical Device Recall notices, reply forms and a copy of Medline's Recall Notice to the their customers. The letter identified the product, the problem, and the action to be taken by the customer. Navilyst Medical, Inc. (an AngioDynamics Company), the manufacturer of the Xcela" PICC w/PASV, the BioFlo PICC w/ Endexo, and the BioFlo PICC w/ Endexo and PASV is conducting a medical device recall based on information received from Medline. Medline has determined that the sterile gloves listed in their Recall Notification dated August 3, 2016 may contain an incorrect expiration date. Actions to be taken: - Customers should immediately remove the affected product from inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). - Segregate this product in a secure location for return to Navilyst Medical. - Immediately forward a copy of this recall notification to all sites to which customers may have further distributed affected product. Customers should also promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return) via email to recall@angiodynamics.com. Customers with questions can call 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday  Friday: Eastern Standard Time). For questions regarding this recall 518-792-4112.
Quantity in Commerce75 packages (boxes of 5)
DistributionNationwide Distribution including AZ, CA, FL, GA, HI, IL< IN< KS, LA, MI, MN, MO, ND, NM, OH, OR, PA, TN, TX, WA & the District of Columbia.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LJS
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