OptiChamber Diamond Spacer Recalled Due to Temperature Exposure During Shipping
Cardinal Health is recalling 375 OptiChamber Diamond Spacer devices due to temperature exposure during shipping that may cause inaccurate medication delivery results. Affected devices were distributed to 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 recall involving a medical device with potential for harm through inaccurate medication delivery. No illness or injury has been reported. Per the rubric, a risk-of-harm medical device without reported injury scores 3 (High).
Plain-English summary
Cardinal Health Inc. is recalling 375 OptiChamber Diamond Spacer devices (Item Number 4742326) distributed nationwide to Florida, Georgia, and South Carolina. The spacer is a respiratory device used with inhalers to improve medication delivery to patients.
During shipping, the devices were exposed to temperature excursions of 31.9°F, occurring intermittently over a 2-hour and 15-minute period. This temperature exposure may cause the spacers to produce inaccurate results during use.
Affected units include all lot numbers shipped between February 2011 and March 10, 2021 (NDC/UPC: 8373982700). Patients and healthcare providers who have received these devices should contact Cardinal Health for device replacement or consult with their healthcare provider regarding continued use.
The recalled product
- Product
- OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
- Manufacturer
- Cardinal Health Inc.
- Affected units
- 375
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: 8373982700 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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