Smiths Medical Asd, Inc.

Entity profile compiled from public source records

Public Record Profile Registrations: 0 510(k) filings: 1 Recalls: 10

Known Identifiers & Locations

FEI Numbers 2183502, 3012307300
Owner Operator Numbers N/A
Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (1)

Submission # Device Name Decision Date Decision Description Action
K083336 LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL 2009-06-03 Substantially Equivalent View Details

FDA Recall History (10)

Recall # Product Description Initiation Date Status Action
Z-0004-2012 Smiths Medical, CADD-Solis ambulatory infusion pumps, Models 2100, REF 21-2101-0200-51 and 2110, REF 21-2111-0100-51, Rx Only. Indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/ surgical wound site), epidural space, or subarachnoid space infusion. Reason: Reports of non-delivery/ significant under-delivery of fluids when the CADD Medication Cassette Reservoir is not correctly latched to the pump. EXPANDED: On 7/14/11, Smith Medical expanded this recall to include all consignees with affected pumps. 2011-05-10 Terminated View Details
Z-0010-2025 CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24 Reason: 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. 2024-06-26 Open, Classified View Details
Z-0011-2025 CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24 Reason: 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. 2024-06-26 Open, Classified View Details
Z-0012-2025 CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24 Reason: 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. 2024-06-26 Open, Classified View Details
Z-0013-2025 CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24 Reason: 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. 2024-06-26 Open, Classified View Details
Z-0014-2025 CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24 Reason: 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. 2024-06-26 Open, Classified View Details
Z-0015-2025 CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP Reason: 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. 2024-06-26 Open, Classified View Details
Z-0016-2025 CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP Reason: 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. 2024-06-26 Open, Classified View Details
Z-0017-2025 ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28 Reason: 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. 2024-06-26 Open, Classified View Details
Z-0018-2025 ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28 Reason: 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. 2024-06-26 Open, Classified View Details

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