Portex Unit Dose recall: Sterility Concern
Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿
Why was Portex Unit Dose recalled?
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model # R0059 Lot Number: ¿B360
- Product
- Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿
- Recalling firm
- Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
- Quantity
- 102,000
- Distribution
- Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.
- Recall date
- February 13, 2019
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)