The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

• Babi.Plus 12.5 cm H2O Pressure Relief Manifold Lot: 180718, 181204, 190215. Reworked lot: 190610

• Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold Lot: 180718, 181107, 181127, 190220. Reworked lot: 190220-190610

• Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port Lot: 180806, 180910, 181029, 181105, 181204,190225, 190327

See a full list of affected devices

Note: This recall is associated with the recall of the Babi.Plus Pressure Relief Manifolds Due to Dislodged Valve recall by Teleflex, a distributor for Galemed.

• Distribution Dates:  July 1, 2018 to July 8, 2019
• Devices Recalled in the U.S.:  29,844
• Date Initiated by Firm:  May 30, 2019

Device Use

The Babi.Plus Pressure Relief Manifold is used as part of a breathing circuit designed to assist the breathing of infant patients who weigh no more than 10 kilograms. The affected devices are sold  in multiples sizes, identified above under recalled product. They are used in health care facilities, such as neonatal critical care units, delivery rooms, and pediatric critical care units.

Reason for Recall

Galemed is recalling the Babi.Plus Pressure Relief Manifold system due to complaints that the Pressure Relief Manifold (PRM) in the Babi.Plus 12.5 cm H2O Pressure Relief Manifold does not hold pressure when initially set up on a patient. This issue is due to a dislodged valve not being properly seated, resulting in loss of pressure in the system.

Use of the affected devices may cause serious adverse health consequences, including lower blood oxygen levels, slow heart rate, stopped breathing (apnea), rebreathing of exhaled carbon dioxide by the patient and need for medical intervention and resuscitation. There have been two complaints associated with malfunction. No injuries or deaths were reported.

Who May be Affected

• Pediatric patients who undergo procedures involving the Babi.Plus Pressure Relief Manifold system.
• Health care providers, distributors and Maintenance/Repair or Engineering  Departments of facilities using the Babi.Plus Pressure Relief Manifold system.

What to Do

On May 30, 2019, Galamed issued a Medical Device Recall Notice instructing customers to:

• Within 1 business day, acknowledge receipt of the recall notice.
• As soon as possible, within 5 business days, notify your customers:
  • That a product recall been initiated on the affected products.
  • Indicate the nature of the recall:
    1. Request that the affected lot codes be returned.
    2. Mention that customers who do not or cannot return affected product should be cautioned of the events which has led to this recall.
    3. Within 5 business days of the notice, provide a list of all customers contacted with product code and lot information.

Contact Information

Consumers with questions may contact either their local distributor or GaleMed Corporation in the following manner:

• Teleflex Medical via telephone at 1-866-246-6990 between the hours of 09:00AM and 4:00PM (EST) or via email at recalls@teleflex.com
• Respiralogics, Inc. via telephone at 1-855-473-7747 between the hours of 09:00AM and 4:00PM (PST) or via email at QARA@respiralogics.com
• GaleMed Corporation via telephone at +886 2 87919348, or FAX +886 2 27949259 between the hours of 9:00AM and 6:00PM (GMT +8).  Consumer may also contact the company via e-mail at sales@galemed.com.

Full List of Affected Devices

---

Affected Babi.Plus 12.5cmH2O Pressure Relief Manifold

Distributed by Teleflex Medical under Cat. No. 2691*

* Product which has been removed from the carton or interior packaged may be identified by checking the Catalogue Number and LOT code which is present on the purple colored label on the valve. Additionally, product(s) can be identified by checking the Catalogue Number and UDI information on the labels. This information should be verified by also checking both Catalogue Number and LOT Code on the actual product contained within.

---

Affected Babi.Plus 12.5cmH2O Pressure Relief Manifold

Distributed byRespiralogics, Inc. under Cat. No. 1030, or in a Kit as Cat. No. 1002*

* Product which has been removed from the carton or interior packaged may be identified by checking the Catalogue Number and LOT code which is present on the purple colored label on the valve. Additionally, product(s) can be identified by checking the Catalogue Number and UDI information on the labels. This information should be verified by also checking both Catalogue Number and LOT Code on the actual product contained within.

---

On July 8, 2019 Respiralogics, Inc. distributed reworked product in either Product Code 1030 (Pressure Relief Manifold) or Product Code 1002 (Bubble PAP Valve with Pressure Relief Manifold):

Note: Product UDI code was not changed for either product – see above reference UDI list.

What to Do for Reworked Product

At this time, GaleMed Corporation instructs Customers who have received this reworked product since July 8, 2019 to:

• Inspect your inventory for the affected product codes and lot numbers identified above. If you have affected stock in inventory, immediately discontinue use.
• Notify Respiralogics, Inc either by phone (855-473-7777) or at QARA@respiralogics.com to obtain a Returned Goods Authorization (RGA) code.
• Return the reworked product to Respiralogics, reference the RGA code.

Additional Resources

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.