Z-1921-2026Class II

Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A

Name: Z-1921-2026 Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Creator: Windstone Medical Packaging, Inc.
Published: 2026-03-11
License: https://open.fda.gov/license/

Windstone Medical Packaging, Inc. / initiated 2026-03-11 / Open, Classified / root cause: manufacturing process

FDA source

Windstone Medical Packaging, Inc. began a recall of Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A on 2026-03-11. FDA classified it as Class II and gives the reason as "The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1921-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-11
Posted: 2026-04-22
Recalling firm: Windstone Medical Packaging, Inc.
Product: Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Product code: KDD Kit, Surgical Instrument, Disposable
Reason for recall: The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An URGENT: MEDICAL DEVICE CORRECTION notification letter was sent to customers on 3/11/26. AMS requests that you undertake the following activities: 1. Review your inventory for the affected kits, all lots are impacted. 2. Communicate the notification with all personnel that utilize B Braun Admin. Sets contained within AMS kits. 3. If you have further distributed this product, please identify your distribution partners, and notify them at once of the product notification. Your notification to your customers should include a copy of this notification letter. 4. Please complete and return the AMS Urgent Medical Device Product Notification Response Required form within 5 business days and return via email to [email protected] even if you have no affected product on hand. Please complete the attached AMS Urgent Medical Device Product Notification Response Required form and return it to Aligned Medical Solutions at the Fax number provided on the form. If you do not have the affected product, you must complete and return the form. If you have any questions or concerns, please do not hesitate to contact us at [email protected].
Quantity in commerce: 520 units
Distribution: US Nationwide distribution in the states of GA, OR, TN, and WA.
Product codes and lots: UDI-DI: B098AMS14994A0; Lot Numbers: 224792 228566 230105 230853 234209

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1921-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1919-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1920-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1921-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22

Product code KDD

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)