TELEFLEX-MORRISVILLE: Medical Device Recall in 2019 - (Recall #: Z-0009-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: June 14, 2019

Date Posted: November 13, 2019

Recall Number: Z-0009-2020

Event ID: 83119

Reason for Recall:

Device vented gas below the stated pressure.

Status: Terminated

Product Quantity: 9,312 each

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated