Windstone Medical Packaging, Inc.: AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B

Recall number

Z-3138-2026

Recalling firm

Windstone Medical Packaging, Inc.

Product

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

Status

Open, Classified

Initiated

2026-07-29

Posted

2026-09-10

Terminated

not on file

Reason

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.

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 fieldcorrectiveaction@alignedmedical.com 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

3,260 kits

Distribution

US Nationwide distribution in the states of CA, GA, WA.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

KDD

Firm FEI

1000125955

Firm city

Billings

Firm state

MT

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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