Device product
Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282
Z-1925-2020
Product summary
- Event
- Event 85474
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 26,298 units
- Official record key
device-enforcement:Z-1925-2020
Official wording
Reason: Sterile drapes packaged in an unsealed pouch.
Code information: Impacted Lot Numbers for HH2000 - 1703011, 1703021, 1703031, 1703041, 1703051, 1703061, 1703071, 1703081, 1703091, 1703101, 1703111, 1703121, 1703131, 1703141, 1703151, 1703161, 1703171, 1703181, 1703191, 1703201, 1703211, 1703221, 1703231, 1703241, 1703251, 1703261, 1703271, 1703281, 1703291, 1703301, 1703311, 1704011, 1704021, 1704031, 1704041, 1704051, 1704061, 1704071, 1704081, 1704091, 1704101, 1704111, 1704121, 1704131, 1704141, 1704151, 1704161, 1704171, 1704181, 1704191, 1704201, 1704211, 1704221, 1704231, 1704241, 1704251, 1704261, 1704271, 1704281, 1704291, 1704301, 1705011, 1705021, 1705031, 1705041, 1705051, 1705061, 1705071, 1705081, 1705091, 1705101, 1705111, 1705121, 1705131, 1705141, 1705151, 1705161, 1705171, 1705181, 1705191, 1705201, 1705211, 1705221, 1705231, 1705241, 1705251, 1705261, 1705271, 1705281, 1705291, 1705301, 1705311, 1706011, 1706021, 1706031, 1706041, 1706051, 1706061, 1706071, 1706081, 1706091, 1706101, 1706111, 1706121, 1706131, 1706141, 1706151, 1706161, 1706171, 1706181, 1706191, 1706201, 1706211, 1706221, 1706231, 1706241, 1706251, 1706261, 1706271, 1706281, 1706291, 1706301, 1707011, 1707021, 1707031, 1707041, 1707051, 1707061, 1707071, 1707081, 1707091, 1707101, 1707111, 1707121, 1707131, 1707141, 1707151, 1707161, 1707171, 1707181, 1707191, 1707201, 1707211, 1707221, 1708221, 1709221, 1710191, 1710201, 1710211, 1710221, 1711191, 1711201, 1711211, 1711221, 1711231, 1712021, 1712041, 1712051, 1712061, 1712071, 1712081, 1712091, 1712111, 1712121, 1712131, 1712141, 1712151, 1712161, 1712181, 1712271, 1712281, 1712291, 1712301, 1801031, 1801111, 1805251, 1805261, 1805271, 1805281, 1805291, 1805301, 1805311, 1806011, 1806021, 1806041, 1806051, 1806061, 1806071, 1806091, 1806111, 1806201, 1806211, 1807031, 1807061, 1807071, 1807091, 1807251, 1807261, 1807271, 1808171, 1808181, 1808201, 1808221, 1808231, 1808241, 1808301, 1808311, 1809011, 1809021, 1809031, 1810041, 1810051, 1810061, 1812051, 1812151, 1902231, 1902241, 1902251, 1902261, 1902271, 1902281, 1903011, 1903021, 1903031, 1903181, 1903191, 1903201, 1903211, 1903221, 1903271, 1903281, 1904231, 1904241, 1904251, 1904291, 1905141, 1905151, 1905161, 1905171, 1905211, 1905221, 1905231, 1905241, 1905251, 1906241, 1906251, 1906271, 1906281, 1906291, 1907011, 1907221, 1907231, 1907241, 1907251, 1907261, 1907271, 1907311, 1908011, 1908021, 1908031, 1908051, 1908061, 1908071, 1908081, 1908091, 1908151 HH9006 Spy-Phi Pack Impacted Lot Numbers - 1701x, 1702x, 1703x, 1704x, 1705x, 1706x, 1707x, 1708x, 1709x, 1710x, 1711x, 1712x, 1801x, 1802x, 1803x, 1804x, 1805x, 1806x, 1807x, 1808x, 1809x, 1810x, 1811x, 1812x, 1901x, 1902x, 1903x, 1904x, 1905x, 1906x, 1907x, 1908x, 1909x, 19103. Where x is any alpha numeric character.
Distribution pattern: US - Nationwide & Puerto Rico OUS - Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan, Puerto Rico, South Africa, South Korea, Australia, Chile, China, Germany, France, United Kingdom, Hong Kong, India, Italy, Singapore, Thailand, Romania, Belgium, Sweden, Switzerland, Austria, Malaysia, Finland, Denmark, Israel, Qatar, Kazakhstan, Turkey, Czech Republic, Greece, Russia, Poland, Ireland, Philippines, and New Zealand.
Derived failure modes
-
Labeling or packaging
unsealed pouch