—#189401

Product

medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g. 089-101E h. 888-101NE i. 081-102GEE j. 888-101BE k. 888-101GE l. 888-101GEE m. 081-101RE n. 081-102GE o. 081-102BE p. 888-101RE

FDA product code: FMG — Stopcock, I.V. Set
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K141254
Affected lot / code info: a. 081-101BE, Serial Numbers: 1570340901, 1570344401, 1570344402 b. 081-101GE, Serial Numbers: 1570343301 c. 081-101GEE, Serial Numbers: 1470293701, 1570343401 d. 081-101NE, Serial Numbers: 1570323801, 1570341001, 1570342701, 1570344101, 1660688101, 1670354301 e. 081-102NE, Serial Numbers: 1660636701 f. 081-102RE, Serial Numbers: 1660636601 g. 089-101E, Serial Numbers: 1570316801, 1570342601, 1570344601, 1660670001, 1670347801, 1670355201, 1670359701 h. 888-101NE, Serial Numbers: 1570343001 i. 081-102GEE, Serial Numbers: 1660636901 j. 888-101BE, Serial Numbers: 1570319201, 1570343101, 1570344201, 1670348101, 1670348102 k. 888-101GE, Serial Numbers: 1570343201, 1660688201 l. 888-101GEE, Serial Numbers: 1470312301, 1570343501 m. 081-101RE, Serial Numbers: 1570342901 n. 081-102GE, Serial Numbers: 1660637101 o. 081-102BE, Serial Numbers: 1570316901, 1660637501 p. 888-101RE, Serial Numbers: 1570344301, 1670356201

Why it was recalled

Product has a lack of sterility assurance

Root cause (FDA determination)

Package design/selection

Action the firm took

The firm, Smiths Medical, notified their consignees of the recall by issuing an "URGENT MEDICAL DEVICE FIELD SAFETY NOTICE" dated 3/2018 on 05/10/2018. The notice described the product, problem and actions to be taken. The consignees/customers were instructed to do the following: PLEASE TAKE THE FOLLOWING ACTIONS TO HELP US PROPERLY EXECUTE THIS FIELD SAFETY CORRECTIVE ACTION: 1. Identify any affected Infusion Stopcocks in your possession 2. Determine the number of affected products in your possession and complete the Field Safety Notice (FSN) Response Form attached to this letter within 10 days of receipt; return it to smithsmedicalrecall@stericycle.com. The completed Response Form must be returned even if you do not have any of the affected Infusion Stopcocks in your possession. 3. All affected products must be returned to Stericycle for processing. If the completed Response Form indicates that you have product to return. 4. When you receive the pre-paid shipping labels, package the affected products by lot number. Include a copy of the completed Response Form inside EACH BOX of returned products. 5. FOR DISTRIBUTORS ONLY: If you have distributed any of the affected products to your customers, please immediately notify your customers of this Field Safety Corrective Action and retrieve all affected products. If you have any questions regarding this notification, contact Stericycle via email at the following address: smithsmedicalrecall@stericycle.com.

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: International Distribution to countries of: Armenia, Austria, Germany, Great Britain, Hungary, Italy, New Zealand, Poland, Slovenia, Spain, Sweden, and Switzerland.

Timeline

Recall initiated: 2018-05-10
Terminated: 2023-09-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #189401. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.