On September 5, 2017, Smiths Medical ASD issued a voluntary recall of 71 lots of Sterile Water and Saline for Inhalation USP Products (described in further detail below) that either lacked sufficient documentation to assure sterility or may have been susceptible to leaking. Sterile Water for Inhalation USP (350 mLand 550 mL Humidifier with 5 psi adapter; 500 mL and 1000 mL Pour Bottle) and Saline (0.9% Sodium Chloride USP) Inhalation Solution 5 mL and 15 mL unit dose vialswere distributed nationwide to distributors and hospitals.
On September 5, 2017, Smiths Medical sent Recall Notices and Response Forms to all customers who were shipped affected product from Smiths Medical. In addition, on January 7, 2019, a sub-recall notification was issued for specific lots of Medline labeled or coded Sterile Water or Saline Products that either lacked sufficient documentation to assure sterility or may have been susceptible to leaking. This press release is being issued in cooperation with the US Food and Drug Administration to notify the public that remaining unexpired Sterile Water and Saline for Inhalation USP and Saline Products affected by this recall may still be in customer inventory.
Risk Statement: Lack of sterility assurance or leaking containers could lead to exposure to infectious agents. Smiths Medical has not received any reports of adverse events associated with this recall.
Remaining unexpired products affected by this recall are single patient use prescription devices intended for respiratory therapy. The products are packaged in 350 mL humidifiers (20 per case), 550 mL humidifiers (12 per case), 1000 mL pour bottles (12 per case) and 15mL unit dose saline vials, (144 per case). All lots associated with potential sterility concerns and within expiration were subject to Smiths Medical’s September 5, 2017 voluntary recall and the resulting January 7, 2019 sub-recall. Affected Smiths Medical labeled models and lots that may still be in customer inventory, which were distributed from February 2015 – February 2017, appear below:
| Product Code | Product Name | Lot Number | Expiration Date |
| 0352 | 350 mL Sterile Water USP for Inhalation Prefilled Humidifier | A214 A215 | 04/2019 04/2019 |
| 0552 | 550 mL Sterile Water USP for Inhalation Prefilled Humidifier | A054 A089 A090 | 02/2019 02/2019 02/2019 |
| 1065 | 1000 mL Sterile Water USP Pour Bottle | B209 | 04/2020 |
| R0159 | Unit Dose 15 mL Normal Saline | B067 | 02/2019 |
Specific models and lots of Medline labeled or coded Sterile Water, Saline and Eye Wash products distributed from February 2015 – February 2017 and subject to January 7, 2019 sub-recall, which may be associated with potential sterility concerns and still be in customer inventory, are listed below. These products are distributed by Medline Industries, Inc. under their own private labeling and/or product numbers. The company has been informed of the recall.
| Product Code | Product Name | Lot Number | Expiration Date |
| SRX0352 | Humidifier, Prefilled, Sterile Water, 350 mL, 12 Units/Case | A214 A215 | 04/2019 04/2019 |
| MDX0552 | Humidifier, Prefilled, Sterile Water, 550 mL, 12 Units/Case | A054 A089 A090 | 02/2019 02/2019 02/2019 |
| MDX0552H | Bottle Humidifier, Prefilled, Sterile Water, 550 mL, 1 Each | A054 A089 A090 | 02/2019 02/2019 02/2019 |
| MDX1065 | Water, Sterile, 1000 mL, Bottle, Inhalation | B209 | 04/2020 |
| HCS00350 | Sterile Water for Inhalation USP Prefilled Humidifier | A055 A056 A057 A058 A103 A176 A455 B530 B531 B532 B533 | 02/2019 02/2019 02/2019 02/2019 03/2019 04/2019 09/2020 12/2020 12/2020 12/2020 12/2020 |
| HCS00550 | Sterile Water for Inhalation USP Prefilled Humidifier | A092 B205 B534 | 2/2019 4/2020 12/2020 |
| PTXR0159 | Unit Dose 15 mL Normal Saline, 144 Units/Case | B067 | 02/2019 |
| PTXR0159H | Saline 15 mL Dose Normal 1 Each | B067 | 02/2019 |
Affected product can be identified by the labeling on the immediate bottle. The product was distributed in the United States to Distributors and Hospitals. Smiths Medical notified its distributors and customers via Recall Notice dated September 5, 2017 and Medline Industries, Inc. notified its customers via a sub-recall notification dated January 7, 2019. Impacted product will be returned to Stericycle for destruction.
Any facility with an existing inventory of recalled product (as indicated in the tables above) should stop use and distribution and quarantine the affected product immediately. Customers should notify all users in their facility of this issue. Customers who have further distributed affected product should forward this notification to any accounts that may have received affected product. Please contact Stericycle at smithsmedicalste00100@stericycle.com to arrange for return of any affected product in your possession.
Patients should contact their physician if they have experienced any problems that may be related to the use of this product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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