FDAClass INovember 13, 2019

Babi.Plus 12.5 cm H2O Pressure Relief Manifold recall

Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.

Why was Babi.Plus 12.5 cm H2O Pressure Relief Manifold recalled?

Device vented gas below the stated pressure.

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?

Catalog # 2691 SKU #: XTF0046 Lot #'s: 180806, 180910, 181029, 181105, 181204, 190225 and 190327

Product
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Recalling firm
TELEFLEX-MORRISVILLE
Quantity
9,312 each
Distribution
US nationwide distribution. AL, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TX, VA, WA and WY
Recall date
November 13, 2019
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls