Z-0931-2020Class II

PediaLift Access Device, Device Identifier: B751PDLFT0

Name: Z-0931-2020 PediaLift Access Device, Device Identifier: B751PDLFT0
Creator: PediaLift LLC
Published: 2019-07-03
License: https://open.fda.gov/license/

PediaLift LLC / initiated 2019-07-03 / Terminated / root cause: manufacturing process

FDA source

PediaLift LLC began a recall of PediaLift Access Device, Device Identifier: B751PDLFT0 on 2019-07-03. FDA classified it as Class II and gives the reason as "The firm was unsuccessful in obtaining a satisfactory Certificate of Conformance from the original vendor of the mattress showing that they are in compliance with labeling requirements". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0931-2020
Classification: Class II
Status: Terminated
Initiated: 2019-07-03
Posted: 2020-02-02
Terminated: 2020-05-15
Recalling firm: PediaLift LLC
Product: PediaLift Access Device, Device Identifier: B751PDLFT0
Product code: FMS Bed, Pediatric Open Hospital
Reason for recall: The firm was unsuccessful in obtaining a satisfactory Certificate of Conformance from the original vendor of the mattress showing that they are in compliance with labeling requirements.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Customers were contacted via email on 7/3/19. Customers were instructed to respond to the email so that replacement mattresses could be shipped. Letters dated 11/26/19 accompanied the replacement mattresses sent to customers. The letter instructed customers to please be advised that you must immediately dispose of the old mattress and utilize this replacement mattress. If you have any questions regarding this matter, feel free to contact us. Thank you, Jillena Atchison [email protected] 724-417-9180
Quantity in commerce: 11
Distribution: The products were distributed to the following US states: IN, NJ, NY, OH, and PA
Product codes and lots: Serial Numbers: PCL-HDPE-DL-1, PCL-HDPE-DL-2, PCL-HDPE-DL-3, PCL-HDPE-DL-4, PCL-HDPE-DL-5, PCL-HDPE-DL-6, PCL-HDPE-DL-7, PCL-HDPE-DL-8, PCL-HDPE-DL-9, PCL-HDPE-DL-10, PCL-HDPE-DL-11, PCL-HDPE-DL-12

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0931-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0931-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-01

Product code FMS

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)