Z-1516-2021Class II

ACE MDI Spacer with Small Mask -

Name: Z-1516-2021 ACE MDI Spacer with Small Mask -
Creator: Smiths Medical ASD Inc.
Published: 2021-03-31
License: https://open.fda.gov/license/

Abbott Medical / initiated 2021-03-31 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters and with... on 2021-03-31. FDA classified it as Class II and gives the reason as "The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels". 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-1516-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-31
Posted: 2021-04-29
Terminated: 2023-01-31
Recalling firm: Abbott Medical
Product: ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters and with mechanically ventilated patients.
Product code: CAF Nebulizer (Direct Patient Interface)
Reason for recall: The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A Recall notification letter titled, "URGENT MEDICAL DEVICE FIELD SAFETY NOTICE" was sent to consignees beginning on 03/31/2021 via email. Consignees were notified to follow the instructions listed in the Recall Notice. Consignees were instructed to identify any affected devices in their possession (listed in the Recall Notice). If consignees have affected devices in their possession, the notice instructs them to inspect devices to determine if the device label matches the shipping box labels. The consignees should complete the response form and return to Smiths Medical. After the completed Field Safety Response Form has been submitted to [email protected], the consignee will be contacted to arrange for return of any affected product. Distributors were instructed in the notice to immediately notify their customers who may have received affected devices of the Recall and provide them a copy of Recall Notice and the accompanying Response Form.
Quantity in commerce: 250 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of PA and MN. The countries of Columbia, Germany, Greece, Hong Kong, Qatar, Thailand, and United Arab Emirates.
Product codes and lots: Device Model Number: 11-1122; Lot Number: 3809856

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1516-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1515-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-05	2021-04-29
Z-1516-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-05	2021-04-29

Product code CAF

K961973Class IIDhd Ace with Mask KitDhd Diemolding Healthcare Div. / cleared 1996-08-15

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)