What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433) and recall number Z-1919-2026, then follow Windstone Medical Packaging, Inc.'s recall instructions.

Has Windstone Medical Packaging, Inc. had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 5 total FDA actions tied to Windstone Medical Packaging, Inc., including 5 recalls and 0 warning letters.

Recall Record: Class II Recall: Custom Convenience Kits Pre Op Kit - NS,… by Windstone Medical Packaging, Inc.

At a glance: Windstone Medical Packaging, Inc. recalled Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433 on 2026-04-29. FDA classified this action as a Class II recall (recall number Z-1919-2026). 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 (additional items listed in FDA's full record). Recall status: Ongoing. This is a device-category FDA recall record.

Key facts

Recalling firm	Windstone Medical Packaging, Inc.
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
Classification	Class II
Recall number	Z-1919-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
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).

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433 -- and the recall number Z-1919-2026. If it matches, stop using or distributing it and contact Windstone Medical Packaging, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Windstone Medical Packaging, Inc. and the affected product is described in FDA's record as: Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433. FDA's stated reason for the recall is: 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 (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-1919-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Windstone Medical Packaging, Inc.’s FDA history

Argus HQ has recorded 5 total FDA actions tied to Windstone Medical Packaging, Inc.: 0 warning letters, 5 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What was recalled and why?: Windstone Medical Packaging, Inc. recalled Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433. FDA's record states the reason for recall 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 Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from (additional items listed in FDA's full record). The recall is.
How serious is this recall?: FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
What should someone who has this product do?: Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433) and recall number Z-1919-2026, then follow Windstone Medical Packaging, Inc.'s recall instructions.
Has Windstone Medical Packaging, Inc. had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 5 total FDA actions tied to Windstone Medical Packaging, Inc., including 5 recalls and 0 warning letters.

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Full FDA history for Windstone Medical Packaging, Inc.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Recall Record: Class II Recall: Custom Convenience Kits Pre Op Kit - NS,… by Windstone Medical Packaging, Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-windstone-medical-packaging-inc-z-1919-2026

MLA

"Recall Record: Class II Recall: Custom Convenience Kits Pre Op Kit - NS,… by Windstone Medical Packaging, Inc.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-windstone-medical-packaging-inc-z-1919-2026.

Chicago

Argus HQ Research. "Recall Record: Class II Recall: Custom Convenience Kits Pre Op Kit - NS,… by Windstone Medical Packaging, Inc.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-windstone-medical-packaging-inc-z-1919-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_windstone_medical_packaging_inc_z_1919_2026_2026,
  title = {Recall Record: Class II Recall: Custom Convenience Kits Pre Op Kit - NS,… by Windstone Medical Packaging, Inc.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-windstone-medical-packaging-inc-z-1919-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗