Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog #… recallZ-0009-2020 · Teleflex-Morrisville · initiated Jun 14, 2019

Why it was recalled

Device vented gas below the stated pressure.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number

Z-0009-2020

Recall class

Class I (most serious)

Status

Terminated

Initiated by the company

Jun 14, 2019

Posted by the FDA

Nov 7, 2019

Recalling firm

Teleflex-Morrisville

Quantity

9,312 each

Product code

BZD

FDA submissions

K110383

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 description

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

Other devices under the same FDA submission

1 device cleared under K110383 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Babi.Plus BC23-HD

  Galemed Corporation · Ventilator, Non-Continuous (Respirator)
  1 recall0 reports