Agency classClass IIOur severity:High FDA (Devices)·Z-2648-2020·Announced 2020-07-29

Carefusion Safe-T-Centesis 6 Fr Catheter Drainage Tray Recalled for Valve Leaks

Carefusion 2200 Inc is recalling Safe-T-Centesis 6 Fr Catheter Drainage Trays because internal valve leaks may introduce up to 30cc of air into patients.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect that poses a risk of harm (air introduction) to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Carefusion 2200 Inc is recalling the Safe-T-Centesis 6 Fr Catheter Drainage Tray (Catalog: PIG1260T; UDI: 50885403108363). The recall involves specific batches of the product, including 0001319266, 0001320359, and 0001320361, among others listed in the agency record.

The recall is due to a defect where the Universal Drainage Set (UDS) may contain valves that leak internally. This defect may result in the introduction of up to 30cc of air into the patient. The product was distributed to 370 US customers and 13 distributors across numerous states, including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.

Healthcare facilities and distributors should stop using the affected products and contact the recalling firm for instructions on return or replacement. The source text does not specify a particular action for individual consumers, as the product is distributed to institutional customers.

The recalled product

Product: Safe-T-Centesis 6 Fr Catheter Drainage Tray
Manufacturer: Carefusion 2200 Inc
Category: Medical Device — Catheter / Drainage
Hazard: air-introduction
valve-leak

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Catalog: PIG1260T
UDI: 50885403108363
Batches: 0001319266
0001320359
0001320361
0001321495
0001321903
0001322646
0001323766
0001324093
0001324318
0001331342
0001332814
0001332817
0001333972
0001335443
0001335444
0001335695
0001336580
0001336581

Distribution

Distributed in 46 states:

Part of a larger recall action

This product is one of 14 recalled by Carefusion 2200 Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

Same manufacturer · Carefusion 2200 Inc

See all →

High
Endoscopic surgical clamp recalled for defective rotation knob
FDA (Devices) · 2023-08-23
High
Surgical Clamp Recall: Rotation Knob May Crack or Break
FDA (Devices) · 2023-08-23
High
Endoscopic surgical graspers recalled for potential rotation knob cracking
FDA (Devices) · 2023-08-23
High
Endoscopic Surgical Dissectors Recalled for Potential Rotation Knob Cracking
FDA (Devices) · 2023-08-23
High
Endoscopic surgical graspers recalled for potential rotation knob failure
FDA (Devices) · 2023-08-23

Same hazard · air introduction