FDAClass IIDecember 14, 2016

Xcela Power Injectable PICC Maximal Barrier Nursing Kit recall

Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and…

Why was Xcela Power Injectable PICC Maximal Barrier Nursing Kit recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch/Lot: 505722, 5056512

Product
Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and…
Recalling firm
Angiodynamics Inc. (Navilyst Medical Inc.)
Quantity
75 packages (boxes of 5)
Distribution
Nationwide 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.
Recall date
December 14, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls