# FDA recall Z-2034-2018

> **Joerns Healthcare** · Class II · device recall initiated 2018-05-03.

## Product

ProCair Mattress:  (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280  (b) PROCAIR PLUS 36X80, MATERIAL NUMBER 222-3680  (c) PROCAIR PLUS 84" MATTRESS, MATERIAL NUMBER 222-6384    Product Usage:  Non powered flotation therapy mattress. The device is intended to treat or prevent decubitus ulcers (bed sores).

## Reason for recall

Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses.  For the identified serial number range of P.R.O. Matt and ProCair Mattresses incorrect connectors (part #s 206-0401 & 206-0405) were provided by a Joerns supplier without the required internal shutoff valves, these shutoff valves prevent air from escaping from the mattress air cells.

## Distribution

Worldwide Distribution - US Nationwide in the states of UK, Canada, Holland

## Key facts

- **Recall number:** Z-2034-2018
- **Recalling firm:** Joerns Healthcare
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-03
- **Report date:** 2018-06-06
- **Termination date:** 2023-09-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Arlington, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2034-2018

## Citation

> AI Analytics. FDA recall Z-2034-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2034-2018. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
