Z-0009-2020Class I

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

Name: Z-0009-2020 Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators
Creator: Teleflex-Morrisville
Published: 2019-06-14
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2019-06-14 / Terminated / root cause: design

FDA source

TELEFLEX-MORRISVILLE began a recall of Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators on 2019-06-14. FDA classified it as Class I and gives the reason as "Device vented gas below the stated pressure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0009-2020
Classification: Class I
Status: Terminated
Initiated: 2019-06-14
Posted: 2019-11-07
Terminated: 2024-06-12
Recalling firm: Teleflex Medical
Product: Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Product code: BZD Ventilator, Non-Continuous (Respirator)
Reason for recall: Device vented gas below the stated pressure.
Root cause tag: design
FDA root cause: Device Design
Action: On June 14 the firm sent communication with the following instructions: 1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above. 2. Using the provided customer letter and recall acknowledgement form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. In the event that an alternative approach is needed, contact Teleflex Medical Customer Service for more information at 1-866-246-6990. 4. To return recalled products to Teleflex Medical, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. 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 product to Teleflex Medical. 5. Once you have completed returning all of the recalled products from your own inventory, and collecting and consolidating all of the recalled products from your customers, please check the box on the enclosed Recall Acknowledgment Form that indicates that you have completed the recall and fax it to 1-855-419-8507, Attn: Customer Service, or email it to [email protected]. This will allow us to document completion of the recall. 6. If you and your customers 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 [email protected]. This will allow us to document your receipt of this letter.
Quantity in commerce: 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
Product codes and lots: Catalog # 2691 SKU #: XTF0046 Lot #'s: 180806, 180910, 181029, 181105, 181204, 190225 and 190327

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0009-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0009-2020	Class I	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-06

Product code BZD

K110383Class IIBabi*plus Pressure Relief Manifold - 10Cm H20, 12.5Cm H20, 15Cm H20A Plus Medical / cleared 2011-08-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)