Catheterization Kits containing Angiographic Syringes with… recallZ-0621-05 · Hospira Inc. · initiated Nov 2, 2004
Terminated All recalls posted in March 2005
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 Hospira 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
Syringes could possibly allow air to enter the patient's vascular system.
FDA root cause category: Other
What the company is doing
Consignees were notified by letter on 11/10/04 or by telephone on 11/11/04.
Recall details
- Recall number
- Z-0621-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 2, 2004
- Posted by the FDA
- Mar 15, 2005
- Recalling firm
- Hospira Inc.
- Quantity
- 62080 kits
- Product code
- DQO
- FDA submissions
- K932141
- Distribution
- Domestic distribution: Nationwide, including 2 military/VA facilities. International distribution: Spain, Belgium, Greece, Japan, and France.
Product description
Catheterization Kits containing Angiographic Syringes with rotator connector.
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
List Numbers: 460690403; 460690469; 460710409; 460710468; 460730411; 460730412; 460730414; 460730455; 460730470; 460730472; 460750442; 460750461; 460780417; 460780453; 460790418; 460830405; 460830411; 460830431; 460830470; 460830471; 460830473; 460840444; 460840454; 460840463; 460840475; 460870444; 460870455; 460870464; 460870467; 460870471; 460880477; 460890413; 460890419; 460890456; 460890461; 460890465; 460890471; 460890478; 460900407; 460900420; 460900465; 460900473; 460920412; 460920422; 460920431; 460920454; 460920455; 460920470; 460930404; 460930418; 460930419; 460930426; 460930468; 460930478; 460950404; 460950405; 460950417; 460950426; 460950429; 460950433; 460950436; 460950437; 460950439; 460950443; 460950444. Lot Numbers: 09284SN; 10004SN; 10019SN; 10026SN; 10042SN; 11007SN; 10008SN; 11081SN; 11085SN; 11122SN; 11182SN; 11225SN; 11228SN; 11245SN; 11272SN; 11295SN; 11313SN; 12022SN; 12039SN; 12074SN; 12075SN; 12091SN; 12116SN; 12128SN; 12131SN; 12250SN; 12253SN; 12281SN; 12282SN; 12284SN; 13016SN; 13033SN; 13060SN; 13096SN; 13123SN; 13189SN; 13193SN; 13271SN; 13275SN; 13283SN; 13285SN; 13292SN; 13294SN; 13296SN; 14018SN; 14107SN; 14128SN; 14129SN; 14141SN; 14144SN; 14182SN; 14232SN; 14236SN; 14242SN; 14249SN; 14269SN; 14298SN; 14302SN; 14306SN; 14309SN; 15020SN; 15036SN; 15061SN; 15123SN; 15126SN; 15149SN; 14161SN; 15162SN; 15163SN; 15164SN; 15171SN; 15173SN; 15224SN; 15241SN; 15245SN; 15250SN; 15253SN; 15257SN; 16007SN; 16013SN; 16032SN; 16045SN; 16052SN; 16084SN; 16088SN; 16137SN; 16213SN; 16227SN; 16235SN; 16273SN; 16274SN; 16279SN; 16287SN; 17019SN; 17084SN; 17086SN; 17105SN; 17106SN; 17116SN; 17133SN; 17149SN; 17151SN; 17204SN; 17211SN; 17220SN; 18004SN; 18008SN; 18021SN; 18022SN; 18045SN; 18055SN; 18066SN; 18116SN; 18118SN; 18127SN; 18128SN; 18134SN; 18147SN; 18156SN; 18161SN; 18239SN; 18249SN; 18250SN; 18284SN; 18290SN; 19010SN; 19074SN; 19090SN; 19104SN; 19156SN; 19182SN; 20024SN; 20064SN; 20065SN; 20067SN; 20069SN; 20073SN; 20082SN; 20085SN; 20171SN; 20174SN; 20224SN; 20225SN; 21137SN; 21209SN; 21218SN; 22213SN.
Other devices under the same FDA submission
5 devices cleared under K932141 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ICU Medical 46100-91Icu Medical, Inc. · Catheter, intravascular, diagnostic13 reports
- ICU Medical 46100-83Icu Medical, Inc. · Catheter, intravascular, diagnostic2 reports
- ICU Medical 42052-01Icu Medical, Inc. · Catheter, intravascular, diagnostic1 report
- ICU Medical 46080-02Icu Medical, Inc. · Catheter, intravascular, diagnostic1 report
- ICU Medical 46098-75Icu Medical, Inc. · Catheter, intravascular, diagnostic1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 30478).
- Z-0617-05 · TerminatedAngiographic Syringe, 10 cc Thumb Ring with Rotator Reservoir.
- Z-0618-05 · TerminatedAngiographic Syringe, 12 cc Thumb Ring with Rotator Reservoir.
- Z-0619-05 · TerminatedAngiographic Syringe, 12 cc Thumb Ring with Rotator Non-Reservoir.
- Z-0620-05 · TerminatedAngiographic Syringe, 12 cc Palm Pad with Rotator Reservoir.
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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