FDA Device Recall Z-0016-2025: Smiths Medical ASD Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0016-2025.

Recall Res Number

Z-0016-2025

Recalling Firm / Manufacturer

Smiths Medical ASD Inc.

FEI Number

3012307300

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2024-06-26

Date Posted

2024-10-18

Date Terminated

N/A

Product Code

FPA

Event Number

95305

Product Quantity

8976 units

Product Description CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP

Reason for Recall Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

Action Details Smiths Medical issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 06/26/2024 via mail. The notice explained the issue, potential risks, and requested the affected product be quarantined, and the response for returned to initiate the return and replacement process. Distributors were directed to notify their customers. For further inquires: Product complaints or adverse events: productcomplaints@icumed.com 1-(866)-216-8806 Additional information or technical assistance 1-(800)-241-4002, option 3 tsc.support@icumed.com

Distribution Pattern Worldwide distribution.

Code Information / Serial Numbers UDI/DI NA, Lot/Serial Numbers: 4013366, 4034019, 4037749, 4034021, 4040248, 4042841, 4048891, 4052407

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Sterigenics EO Canada, Inc. Registration: 9611665 View Registration
FENWAL INTERNATIONAL, INC. Registration: 9612051 View Registration
Baxter Healthcare, S.A. Registration: 9612052 View Registration
Vantive Manufacturing Pte. Ltd. Registration: 9612057 View Registration
ELCAM MEDICAL A.C.A.L. Registration: 9612152 View Registration
B. BRAUN DOMINICAN REPUBLIC INC. Registration: 9614279 View Registration
ICU Medical Costa Rica Ltd. Registration: 9615050 View Registration
ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD Registration: 9615588 View Registration
CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG Registration: 9615817 View Registration
KAWASUMI LABORATORIES (THAILAND) CO., LTD. Registration: 9615908 View Registration
SISTEMAS MEDICOS ALARIS, S.A De C.V. Registration: 9616066 View Registration
DAVOL SURGICAL INNOVATIONS Registration: 9616067 View Registration
Convertors de Mexico S. de R.L. de C.V Registration: 9616088 View Registration
Cardinal Health Mexico 244 S de RL de CV Registration: 9616099 View Registration
ICU Medical Healthcare Manufacturing S.A. de C.V. Registration: 9616567 View Registration
MERIT MEDICAL IRELAND, LTD Registration: 9616662 View Registration
Takeda Manufacturing Austria AG Registration: 9616848 View Registration
Becton, Dickinson & Company (BD) Registration: 9617032 View Registration
ALLERGAN Registration: 9617229 View Registration
SARSTEDT AG & CO. KG Registration: 9617475 View Registration
BARD REYNOSA S.A. DE C.V. Registration: 9617592 View Registration
ICU MEDICAL DE MEXICO, S. de R.L. de C.V. Registration: 9617594 View Registration
ICU Medical Healthcare Manufacturing S.A. de C.V. Registration: 9617604 View Registration
ZHEJIANG MEDICINES & HEALTH PRODUCTS I/ E CO., LTD. Registration: 9680222 View Registration
CARDIO TECHNICS S.A. DE C.V. Registration: 9680306 View Registration
Avent S. de R.L. de C.V. Registration: 9680425 View Registration
TIANJIN HANACO MEDICAL CO.,LTD. Registration: 9680448 View Registration
HENNIG ENTERPRISES EUROPE S.R.L. Registration: 9680787 View Registration
Arrow Internacional de Chihuahua S.A. de C.V. Registration: 9680794 View Registration
TERUMO EUROPE N.V. Registration: 9681413 View Registration
Coastline de Mexico SA de CV Registration: 9681572 View Registration
FRESENIUS KABI DEUTSCHLAND GMBH Registration: 9681819 View Registration
KOFU FACTORY OF TERUMO CORP. Registration: 9681835 View Registration

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This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0016-2025

Recall Parameters & Description

Related Establishments / Registrations

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