Agency classClass IIOur severity:Low FDA (Devices)·Z-1146-2017·Announced 2017-02-15

Thayer MiniSpacer MDI Adapter Recalled for Incorrect Labeling

Thayer Medical Corporation is recalling 2,550 MiniSpacer MDI adapters because the insert and case labels incorrectly state the connection size.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is due to a cosmetic labeling error where the printed connection size (22mm) does not match the actual device specification (15mm). This is a documentation issue with no reported injuries or direct health hazard.

Plain-English summary

Thayer Medical Corporation is recalling 2,550 units of the Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1543A. The recall was initiated because the insert and case label description of the device incorrectly reads "Counter Incrementing Actuator with 22mm O.D./I.D. Connections." The actual device features 15 mm outer diameter and 15 mm inner diameter connections.

The affected products are non-sterile, single-use items intended to dispense aerosolized medication into a breathing circuit or ancillary circuits. These devices are indicated for patients on a breathing circuit in short and long-term critical care environments and are installed and operated by licensed healthcare practitioners. The recall covers units with lot codes 160214, 160301, and 160901, which were distributed nationwide.

Healthcare practitioners and facilities should check their inventory for the affected reference number and lot codes. If the device is found, it should be removed from use and returned to Thayer Medical Corporation or the distributor for credit or replacement, as per standard recall procedures.

The recalled product

Product: Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1543A. The 15 mm Dual Spray MiniSpacer with Counter Incrementing Actuator is a non-sterile, single-use item, intended to dispense aerosolized medication into a…
Manufacturer: Thayer Medical Corporation
Category: Medical Device — Respiratory / Inhalation
Hazard: mis-labeling
Affected units: 2,550

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 (3)

160214
160301
160901

Distribution

Distributed nationwide across the United States.

Same manufacturer · Thayer Medical Corporation

See all →

Moderate
Thayer Medical Recalls AirLife MiniSpacer MDI Adapters Due to Molding Defect
FDA (Devices) · 2012-07-11

Same hazard · mis labeling