AeroChamber PLS Spacer Recalled Due to Temperature Exposure During Shipping
Cardinal Health is recalling AeroChamber PLS spacers exposed to freezing temperatures during shipping, which may cause inaccurate drug delivery results. Affected units shipped between February and March 2021 in Florida, Georgia, and South Carolina.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for a risk-of-harm product. Temperature exposure may cause spacers to malfunction, posing serious risk to asthma patients, though no injuries have been reported. This fits the High severity criterion for risk-of-harm products without reported injury.
Plain-English summary
Cardinal Health Inc. is recalling AeroChamber PLS W/MASK LRG BLU inhaler spacers (Item Number 1496033) due to temperature exposure during shipping.
During transit, affected devices experienced temperature excursions of 31.9°F occurring intermittently over a 2 hour and 15 minute period. These temperature conditions may cause the spacers to produce inaccurate results.
The recall affects 100 units distributed in Florida, Georgia, and South Carolina. All affected units carry NDC/UPC code 456074613 and lot numbers shipped between February 23, 2021 and March 10, 2021.
The recalled product
- Product
- AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033
- Manufacturer
- Cardinal Health Inc.
- Category
- Medical Device — Inhaler Spacer
- Affected units
- 100
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- NDC/UPC: 456074613 All lots numbers shipped from 2/23/201 to 3/10/2021
Distribution
Part of a larger recall action
This product is one of 14 recalled by Cardinal Health Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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