Z-3138-2026Class II

AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B

Name: Z-3138-2026 AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
Creator: Windstone Medical Packaging, Inc.
Published: 2026-07-29
License: https://open.fda.gov/license/

Windstone Medical Packaging, Inc. / initiated 2026-07-29 / Open, Classified

FDA source

Recall record

Recall number: Z-3138-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-29
Posted: 2026-09-10
Recalling firm: Windstone Medical Packaging, Inc.
Product: AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
Product code: KDD Kit, Surgical Instrument, Disposable
Reason for recall: The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulation.
FDA root cause: Equipment maintenance
Action: An URGENT: MEDICAL DEVICE RECALL notification letter dated 7/29/26 was sent to customers. AMS requests that you undertake the following activities: 1. Immediately check your inventory for the recalled products listed above and place them under quarantine. 2. Due to the manufacturing process any finished sterilized packs remaining in inventory, or at your facility will require over labeling for all products affected by this recall. Packs will be labeled with a sticker attached to each pack. This sticker will read: RECALL NOTICE BD announced the recall of 70084 PHARMACY NACL .9% 100ML BAG contained in this kit after it was sealed and sterilized. All other components in the kit are not affected by this recall. "At the time the kit is opened for use any BD PHARMACY NACL .9% 100ML BAG should be identified and set aside. "The recalled BD PHARMACY NACL .9% 100ML BAG should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution. 3.Complete the attached Recall Reply Form listing all inventory of affected product by lot number and quantity. 4.If you have further distributed this product, please identify your distribution partners, and notify them at once of the product recall. Your notification to your customers should include a copy of this notification letter. 5.Please complete the Recall Reply Form within 5 business days and return via email to [email protected] even if you have no affected product on hand. 6.Indicate on the Recall Reply Form if replacement PHARMACY NACL .9% 100ML BAG are needed. Please complete the attached AMS Recall Reply 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 AMS Recall Reply Form. Replacement BD Fresenius Kabi Freeflex IV Container contained within the kit will be issued upon request and completion of the attached Recal
Quantity in commerce: 3,260 kits
Distribution: US Nationwide distribution in the states of CA, GA, WA.
Product codes and lots: UDI-DI:B098AMS12394B0; Lot Numbers: 241907, 241223, 241034, 240904, 240705, 240633, 240269, 238361, 238197, 238146, 238085, 238084, 238041, 237957, 237901, 237843, 237663, 237444, 237443, 236863, 236740, 236250, 236249, 236111, 235602, 235601, 235442, 235026, 235025, 235024, 235023, 234889, 234839, 234458, 233931, 233930, 233762, 233328, 233224, 231945, 231124, 231123, 231122, 231081, 231080, 230970, 230969, 230968, 230697, 230696, 230695, 230694, 230098, 229977, 229825, 229824, 229656, 229655, 229565, 229390, 229238, 229141, 229140, 228793, 228718, 228572, 228263, 227828, 227540, 227112, 226969, 226897, 226841, 226714, 226572, 226382, 225455, 225276, 225275, 223916, 223915, 223914, 223913

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3138-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3138-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-16	2026-09-10

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 2026-09-18. View this recall on fda.gov (opens on fda.gov)