CLASS II Device recall · Reported 1 Oct 2014 · FDA Enforcement Report
9% Sodium Chloride Injection recalled by Centurion Medical Products
Centurion Medical Products is recalling 9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe, distributed in 20 states. The recall was initiated on 25 Jul 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2670-2014
- FDA event ID
- 68989
- Recalling firm
- Centurion Medical Products, Williamston, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jul 2014
- FDA classified
- 19 Sep 2014
- Reported
- 1 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Syringes & Needles
Timeline
| 25 Jul 2014 | Recall initiated by company | |
| 19 Sep 2014 | Classified by FDA | +56 days |
| 1 Oct 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Unit packages may exhibit open seals which impacts package integrity and potentially product sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits. Recalled product is attached to the outside of the Convenience Kits.
Where it was distributed
The product was distributed domestically to the following states: UT, WI, TX, NE, AZ, CA, IA, MD, NY, OK, PA, TN, TX, VA, NC, IL, MA, OR, WA, IN, SD.
ArizonaCaliforniaIowaIllinoisIndianaMassachusettsMarylandNorth CarolinaNebraskaNew YorkOklahomaOregonPennsylvaniaSouth DakotaTennesseeTexasUtahVirginiaWashingtonWisconsin
Questions about this recall
Is 9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe recalled?
Yes. Centurion Medical Products recalled 9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe on 25 Jul 2014. The recall is Class II and its status is Terminated. Recall number Z-2670-2014.
Why was it recalled?
Unit packages may exhibit open seals which impacts package integrity and potentially product sterility.
Which lots are affected?
0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) Syringes Ref #306553, Lot Numbers 4128353, 3046276, 3024261 were utilized in the following Centurion convenience kits: Kit Code/Description: CVI3210/UNIVERSAL CENTRAL LINE INSERTION, Lot Numbers: 2013082850, 2013092650; Kit Code/Description: CVI3240/PORT ACCESS KIT, Lot Number: 2013111180; Kit Code/Description: CVI3425/CVC UNIVERSAL BUNDLE, Lot Numbers: 2013081350,2013082950, 2013091250; Kit Code/Description: CVI3525/UNIVERSAL BUNDLE PACK, Lot Number: 2013052880; Kit Code/Description: CVI3535/CENTRAL LINE INSERTION TRAY, Lot Numbers: 2013092450, 2013081950; Kit Code/Description: DT10560/INFUSION PORT ACCESS KIT, Lot Number: 2013061780; Kit Code/Description: DT10620/FISTULA KIT, Lot Number: 2013082150; Kit Code/Description: DT11270/VAD KIT, Lot Number: 2013051380; Kit Code/Description: DT11390/ONCOLOGY PORT ACCESS TRAY (MED GLOVES), Lot Numbers: 2013052080, 2013072980; Kit Code/Description: DT11395/ONCOLOGY PORT ACCESS (NO GLOVES), Lot Numbers: 2013052880, 2013111180; Kit Code/Description: DT12955/UNIVERSAL PROCEDURE PACK, Lot Number: 2013091750; Kit Code/Description: DT13610/PICC INSERTION KIT, Lot Numbers: 2013061780, 2013062480; Kit Code/Description: DT13775/PORT ACCESS/CENTRAL LINE TRAY, Lot Number: 2013052080; Kit Code/Description: DT14645/PORT ACCESS TRAY, Lot Number: 2013120280; Kit Code/Description: DT14680/CAP CHANGING KIT, Lot Numbers: 2013061080, 2013061780; Kit Code/Description: DT14835/CAP CHANGE KIT, Lot Number: 2013111180; Kit Code/Description: DT14860/PORT DRESSING CHANGE KIT WITH MED SHIELD, Lot Number: 2013102880; Kit Code/Description: DT15060/SINGLE PORT ACCESS TRAY W/SORBAVIEW, Lot Numbers: 2013050680, 2013040180, 2013061080; Kit Code/Description: DT15220/STERILE CAP CHANGE, Lot Numbers: 2013052880, 2013061080; Kit Code/Description: DT16040/PORT ACCESS TRAY, Lot Numbers:, 2013052880,2013061780, 2013072980, 2013111180; Kit Code/Description: DT17300/NEONATAL CAP CHANGE KIT, Lot Numbers: 2013052880, 2013111880; Kit Code/Description: DT17410/ON/OFF KIT & DRESSING CHANGE TRAY, Lot Numbers: 2013050680, 2013061780; Kit Code/Description: DT17880C/DRIVELINE MGMT SYST - PROTOCOL 2, Lot Number: 2013040180; Kit Code/Description: ECVC150/MULTI-LUMEN CVC KIT W/ELS VANTEX CATHETE, Lot Number: 2013091950; Kit Code/Description: ECVC355/ CHARLES COLE CVC INSERTION BUNDLE, Lot Numbers: 2013082050, 2013091950; Kit Code/Description: ECVC510/CENTRAL LINE INSERTION TRAY, Lot Number: 2013081550; Kit Code/Description: ECVC585/CENTRAL LINE INSERTION TRAY BUNDLE, Lot Number: 2013082950; Kit Code/Description: ECVC705/7FR,20CM,3L ANTIMICROBIAL CVC BUNDLE, Lot Number: 2013091750; Kit Code/Description: ECVC740/MULTI-LUMEN CVC BUNDLE, Lot Number: 2013092650; Kit Code/Description: HT5525/V.A.D.KIT, Lot Number: 2013062480; Kit Code/Description: HT5545/SUB-PORT ACCESS TRAY: Lot Number: 2013052880; & Kit Code/Description: IV7610/ARTERIAL LINE INSERTION KIT, Lot Numbers: 2013052080.
Where was it sold?
The product was distributed domestically to the following states: UT, WI, TX, NE, AZ, CA, IA, MD, NY, OK, PA, TN, TX, VA, NC, IL, MA, OR, WA, IN, SD.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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