Recall Class: Class I
Date Recall Initiated: April 15, 2014
Product: Infant Nasal CPAP Prongs (10 Pack) and Bubble CPAP Starter Kits
These affected products were manufactured and distributed from June 6, 2013 through March 25, 2014.
The Nasal Tubing is not affected by this recall.
Use: The Nasal CPAP Prongs connect to the Fisher and Paykel Healthcare FlexiTrunk Patient Interface. The prongs are placed in the patient’s nostrils to deliver continuous positive airway pressure (CPAP) which involves passing air through an infant’s nose. The prongs are used in patients weighing up to 22 pounds in a hospital or clinical setting where the patient is monitored by trained medical staff. The device is not intended to be used as a life supporting device.
Fisher and Paykel Healthcare, Ltd.
15 Maurice Paykel Place, East Tamaki
Auckland, New Zealand
Reason for Recall: Fisher & Paykel Healthcare received 24 reports in which the device has malfunctioned. There were zero injuries and zero deaths. The firm received reports of the affected prongs detaching from the nasal tubing during use, especially when mucous and/or moisture are present. When the affected prongs detach from the nasal tubing, therapy is likely to be interrupted. This may cause low blood oxygen (hypoxemia). The detached prongs may enter an infant’s mouth and present a potential risk of choking and airway obstruction.
The use of the affected product may cause serious adverse health consequences, including death.
Public Contact: Questions about this recall can be directed to Raymond.Yan@fphcare.com at 1-800-792-3912 extension 1423, Monday - Friday, 8 am -5 pm, Pacific Time.
FDA District: Los Angeles District Office
More Information about this Recall:
Starting on April 11, 2014, Fisher & Paykel Healthcare sent its customers an Urgent Medical Device Recall letter. The letter identified the product, problem, and actions to be taken.
Fisher & Paykel Healthcare (FPH) recommends the following actions:
- Identify any Affected Prongs in your inventory by checking the REF and LOT number on the packaging (See recall letter, examples in Figures 3 and 4) or by visually confirming using Figures 1 and 2. For Starter Kits, only the Nasal CPAP Prongs are affected and the rest of the Starter Kit is suitable for use.
- Destroy the Affected Prongs by cutting them in half and disposing of the products.
- Complete Section A ‘Inspection of Stock’ on the Urgent Medical Device Recall Response Form and return it to your FPH Representative.
- Contact your FPH Representative for replacement products.
FPH will work with customers to identify alternative products or potentially alternative therapies until receipt of the previous version of Nasal CPAP Prongs or issue credit. Replacing stock for some customers may take up to several months.
FPH also reminds users to refer to the User Instructions and pay attention to the following warnings:
- Always use pressure monitoring to verify that the patient is receiving the prescribed CPAP level.
- Use patient oxygen monitoring.
- Check that all circuit connections are tight before use and after any adjustment.
FPH is asking customers to inform others within their organizations who need to be aware of this recall and to other customers who have received the affected product.
About Class I Recalls:
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.
|Model Number (REF)||Lot Numbers (LOT)|
|BC3020-10||13060603XX - 14032503XX|
|BC3520-10||13082003XX - 14032503XX|
|BC4030-10||13091903XX - 14032503XX|
|BC4540-10||13082603XX - 14032503XX|
|BC5040-10||13091903XX - 14032503XX|
|BC5050-10||14022603XX - 14032503XX|
|BC5550-10||14022603XX - 14032503XX|
|BC5560-10||14031203XX - 14032503XX|
|BC6060-10||14031203XX - 14032503XX|
|BC6070-10||14031203XX - 14032503XX|
|BC6570-10||14031203XX - 14032503XX|
|Model Number (REF)||Lot Numbers (LOT)|
|BC461-SK||131007 - 140325|
|BC471-SK||131007 - 140325|
|BC490-SK||131007 - 140325|
|BC491-SK||131007 - 140325|
|BC492-SK||131007 - 140325|