Large-Volume IV Administration Sets for use with Deltec… recallZ-0658-06 · Smiths Medical MD, Inc. · initiated Dec 8, 2005
Terminated All recalls posted in March 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical MD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely.
FDA root cause category: Other
What the company is doing
Affected customers were notified of the recall and asked to return or destroy any unused product.
Recall details
- Recall number
- Z-0658-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 8, 2005
- Posted by the FDA
- Mar 18, 2006
- Recalling firm
- Smiths Medical MD, Inc.
- Quantity
- 2 boxes of 40 Admin. Sets (80 sets in total)
- Product code
- FPA
- FDA submissions
- K811933, K991599
- Distribution
- South Carolina, Australia, Canada and Puerto Rico.
Product description
Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps.---- Model Number CC1301 (Reorder No. 21-0334-01) Primary Checkvalve set for Secondary (piggyback) Administration. Sterile, non-pyrogenic. Length 115 inch/292 cm, 27 ml priming volume, 20 drops/ml and 3 SureSite Prepierced Injection sites. Manufactured for Deltec SIMS Deltec, Inc., St. Paul, MN 55112 U.S.A. sims Smiths Industries Medical Systems.
Code information (models, lots, serial numbers)
Lot number MAR04T22
Other devices under the same FDA submission
1 device cleared under K811933, K991599 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CADD 21-7081-24Icu Medical, Inc. · Set, administration, intravascular21 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 34691).
- Z-0659-06 · TerminatedLarge-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. ------Model Number RC4106 (Reorder No. 21-0402-25) Primary Administr…
- Z-0660-06 · TerminatedLarge-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. Model Number 8C290 (Reorder No. 21-0304-01) Speciality Administrat…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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