FDA Medical Device Recalls (openFDA)
Sun Med, LLC: MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126FPC
- Recall number
- Z-2157-2018
- Recalling firm
- Sun Med, LLC
- Product
- MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126FPC
- Status
- Terminated
- Initiated
- 2018-05-24
- Posted
- not on file
- Terminated
- 2020-05-12
- Reason
- 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.
- 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 info@sun-med.com 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 info@sun-med.com
- Quantity
- 2 cases
- Distribution
- IL & OH distributors
- Lot, serial or model codes
- Lot Number: 313315
- 510(k) numbers
- ["K953546"]
- PMA numbers
- not on file
- Product code
- BTM
- Firm FEI
- 1314417
- Firm city
- Grand Rapids
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28