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Pouch containing pediatric probes was labeled as containing adult probes.
Potential extended charge time anomalies.
Potential for early depletion of Implantable Cardioverter Defibrillator battery.
The device has the potential for tip breakage during use.
Only "Pack 'n Play" portable play yards with raised changing tables are part of this recall. They also are sold with an infant bassinet. "GRACO" and "Pack 'n Play" are written on the side of the play yard. These play yards have model numbers 2016, 35235, or model numbers that begin with 9531 or 9533. The last three digits of the model number will vary. The model number can be found on a label on the white plastic center cone under the play yards. "MADE IN CHINA" also is written on the bottom label. Models 2016, 35235, 9531 and 9533 that are currently sold at retail and that have green stickers on the boxes, indicating that the unit has been modified, are not recalled.
Sterility of product is compromised by open seals in packaging.
Wiring pin locking mechanism defective, potential to come apart in surgical site.
The kits were packaged with incorrect dispensing pipettes.
Outer kit mislabeled with an extended expiration date
Degradation of the magnesium sensor could result in low ionozed magnesium patient samples
Invalid test results are being generated due to calibration errors when using calibrator lots 94165M100 and 94164M100.
Design Change
Kits may produce results that are falsely elevated.
Component spring or nut may loosen, detach, and fall into chest of patient during surgical procedure.
Sample wheel may home to the wrong position.
Mislabeled. 7mm balloon labeled 12mm
Sample values may be decreased by between 9 and 12 percent.
Bottled water with the affected push-pull sports caps was sold under the brand names Dannon Fluoride to Go, Pure American, Enon Springs, Alhambra Junior Sport Drinking Water and Sparkletts Junior Sport Drinking Water. The bottled water was sold as singles and multi- packs in 8-oz., 8.5-oz., and .33-liter sizes.