Z-2157-2018Class II

Medline Adult Manual Resuscitator with Medium Adult Mask, Tube Reservoir, Filter, PEEP Valve, CO2 and 7 Ft...

Name: Z-2157-2018 Medline Adult Manual Resuscitator with Medium Adult Mask, Tube Reservoir, Filter, PEEP Valve, CO2 and 7 Ft...
Creator: Sun Med, LLC
Published: 2018-05-24
License: https://open.fda.gov/license/

Salter Labs / initiated 2018-05-24 / Terminated

FDA source

Sun Med, LLC began a recall of MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126FPC on 2018-05-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2157-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-24
Posted: 2018-06-09
Terminated: 2020-05-12
Recalling firm: Salter Labs
Product: Medline Adult Manual Resuscitator with Medium Adult Mask, Tube Reservoir, Filter, PEEP Valve, CO2 and 7 Ft. Oxygen Tubing, Ref Cprm1126fpc
Product code: BTM Ventilator, Emergency, Manual (Resuscitator)
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.
FDA root cause: Mixed-up of materials/components
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]
Quantity in commerce: 2 cases
Distribution: IL & OH distributors
Product codes and lots: Lot Number: 313315

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2157-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2145-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-09
Z-2146-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-09
Z-2147-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-09
Z-2148-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-09
Z-2149-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-09
Z-2150-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-09
Z-2151-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-09
Z-2152-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-09
Z-2153-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-09
Z-2154-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-09
Z-2155-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-09
Z-2156-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-09
Z-2157-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-09
Z-2158-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-09

Product code BTM

K953546Class IIManual Pulmonary ResusicitatorMedical Marketing Concepts / cleared 1996-02-29

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)