MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126P
FDA Recall Z-2158-2018 · Posted None
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Recalling FirmSun Med, LLC
Recall StatusTerminated
Product CodeBTM
Date Initiated2018-05-24
Date Terminated2020-05-12
Product Quantity30 cases
Reason for Recall
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Firm Action
On May 25, 2018 Sun Med, LLC issued URGENT MEDICAL DEVICE PRODUCT REMOVAL notices to two of their customers. On June 1, 2018 Sun Med, LLC issued a press release. Customers were encouraged to take the following actions:
1) Examine inventory, quarantine and cease distribution of impacted product.
2) If customers further distributed product, please identify your customers/consignees and notify them of this product removal. Your notification may be enhanced by including a copy of the removal notice. If you need any assistance contacting your customers, please inform SunMed.
3) Complete and return the Removal Return Response Form via fax to 1-800-400-8820 or via email to [email protected] as soon as possible.
4) Once you return the affected product(s), new corrected replacement resuscitation bags will be provided to you. If you need replacement products to be sent to you urgently, please call SunMed directly.
Customers with questions can call 1-800-433-2797 or email [email protected]
Root Cause
Mixed-up of materials/components
Distribution Pattern
IL & OH distributors
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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