0.9% Sodium Chloride: Brand Name: Product Name/Product recall: Sterility Concern
0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV…
Why was 0.9% Sodium Chloride: Brand Name: Product Name/Product recalled?
Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Product Code/UDI-DI/Lot: 9210/20850020865042/21122520, 21122573, 22032938; 1203-BP/B1501203BP4/22022797; 1205-BP/B1501205BP4/22022789, 23024788; 1210-BP/B1501210BP4/21112359, 21112384, 21112388, 21112441, 21112451, 21122519, 21122550, 21122588, 21122614, 22012632, 22012669, 22012668, 22012672, 22012673, 22012677, 22012689, 21122572, 22012678, 22022824, 22012690, 22022827, 22022853, 22022857, 22032891, 22032923, 22032922, 22032935, 22032936, 22032937, 22032962, 22033016, 22032963, 22033026, 22033038, 22033061, 22033083, 22043095, 22043129, 22043135, 22043154, 22043172, 22043186, 22043210, 22043214, 22043227, 22043240, 22043253, 22053259, 22053270, 22053260, 22053282, 22053281, 22053293, 22053306, 22053333, 22053326, 22053341, 22053364, 22053382, 22063384, 22063411, 22063428, 22063416, 22063459, 22063481, 22063510, 22063523, 22063538, 22063554, 22073576, 22073596, 22073626, 22073668, 22073712, 22083756, 22083766, 22083798, 22083830, 22083894, 22083899, 22083917, 22093934, 22093951, 22093983, 22094015, 22094027, 22094057, 22094058, 22094076, 22094097, 22094121, 22104141, 22104149, 22104168, 22104182, 22104200, 22104226, 22104246, 22104278, 22114301, 22114328, 22114349, 22114366, 22114390, 22114413, 22114433, 22124485, 22124510, 22124529, 23014706, 23014528, 23014755, 23024867, 23045258, 23055569, 23065893, 23065922, 23086215, 23086351, 23096407; PFF001/20810062438895/23014656, 23014671; SS003/20885632389778/23035163, 23055622, 23086334; SS005/20885632389761/23035151, 23055649, 23076007, 23086323; SS010/20885632389754/23024926, 23035099, 23035143, 23045223, 23045305, 23055455, 23055658, 23065737, 23065794, 23065853, 23065958, 23065967, 23075984, 23076039, 23076086, 23076105, 23076121, 23086157, 23086189, 23086248, 23086264; SS010SFR/not distributed.
- Product
- 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV…
- Recalling firm
- Nurse Assist, LLC
- Quantity
- 61,740 Cases
- Distribution
- US Nationwide Distribution: SC AZ, CA, FL, GA, HI, IA, IN, KS, KY, MA, ME, MN, MS, NC, ND, NE, NJ, NV, NY, OH, PA, RI, TX, WA, WI, AK, AL, AR, CO, CT, DC, ID, IL, LA, MD, MI, MO, MT, NH, NM, OK, OR, PR, SD, TN, UT, VA , WI, WV, WY. OUS (foreign) distribution to: Canada
- Recall date
- December 27, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)